Panels › Cardiovascular › Product code DQA · Class 2
Oximeter
Regulation 870.2700
13510(k)s in 12 months (727 all time)
9recalls in 12 months (128 all time)
101recalls that name a 510(k)
Top companies in DQA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M TO MASIMO, Part Number CS08750 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M W/PRINTER, Part Number CS08659 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. Capnostream20 (US) M, Part Number CS08653 Terminated |
DQA | K082268 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03 Terminated |
DQA | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02 Terminated |
DQA | K112368 |
| Jul 31, 2018 | Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (US) N, Part Number CS08651 Terminated |
DQA | K082268 |
| Dec 16, 2016 | Covidien LLC Covidien Nellcor SpO2 Forehead Sensor
Item Code: RS10;
The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rat Terminated |
DQA | K904039 |
| Sep 29, 2016 | Nonin Medical, Inc 8500M Handheld Pulse Oximeter Terminated |
DQA | K893221 |
| Apr 4, 2016 | Merge Healthcare, Inc. MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075),
Product Usage:
Merge Hemodynamics monitors, measures, and records physiologic data from a human Terminated |
DQA | K090662 |
| Apr 4, 2016 | Merge Healthcare, Inc. MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076),
Product Usage:
Merge Hemodynamics monitors, measures, and records physio Terminated |
DQA | K051212 |
| Apr 4, 2016 | Merge Healthcare, Inc. Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047),
Product Usage:
Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac Terminated |
DQA | K051212 |
| Nov 25, 2015 | Masimo Corporation rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpC Terminated |
DQA | K080238 |
| Jul 27, 2015 | Covidien LP (formerly Nellcor Puritan Bennett Inc.) OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. Terminated |
DQA | K123581 |
| Jul 27, 2015 | Covidien LP (formerly Nellcor Puritan Bennett Inc.) OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. Terminated |
DQA | K123581 |
| Dec 31, 2014 | Nonin Medical, Inc SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 Terminated |
DQA | K132402 |
| Nov 13, 2014 | Masimo Corporation Masimo SET uSpO2 Cable
The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and p Terminated |
DQA | K121914 |
| Jun 18, 2014 | Spacelabs Healthcare Inc Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 Terminated |
DQA | K903702 |
| Apr 29, 2013 | Masimo Corporation Rad-8 Pulse Oximeters
The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and p Terminated |
DQA | None listed |
| May 19, 2011 | International Technidyne Corp. AVOXimeter 1000, AVOXimeter 4000
1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced soft Terminated |
DQA | K951485 |
| Feb 22, 2011 | Masimo Corporation Masimo Hemoglobin
Pronto-7 with Rainbow 40 Technology for
easy-to-use spot-check testing of hemoglobin (SpHb),
SpO2, pulse rate, and perfusion index
Pronto-7 rainbow 4D Reusable Sensors are an accesso Terminated |
DQA | K100403 |
| Dec 9, 2010 | Dixtal Medical, Inc. Dixtal Handheld Pulse Oximetry Model 512
Catalog Number: 9100-00 Terminated |
DQA | K032949 |
| Dec 9, 2010 | Dixtal Medical, Inc. Dixtal Handheld Pulse Oximetry Model 513
Catalog Number: 9300-00 Terminated |
DQA | K032949 |
| Apr 15, 2010 | Mindray DS USA, Inc., dba Datascope Patient Monitoring SmarTemp Probe Covers for use with the VS-800 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of Terminated |
DQA | K072235 |
| Apr 15, 2010 | Mindray DS USA, Inc., dba Datascope Patient Monitoring SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010 also distributed in boxes of 2000 (10 individual boxes of 2 Terminated |
DQA | K072235 |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V 2001 Pulse Oximeter with Mars Nurse Call, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K000794 |
| Apr 8, 2010 | Philips Healthcare Inc. 515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K893643 |
| Apr 8, 2010 | Philips Healthcare Inc. 515B Pulse Oximeter, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K893643 |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K913516 |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V 2001 Pulse Oximeter WI - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K000794 |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V 2001 Pulse Oximeter with Mars Nurse Call - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K000794 |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V 2001 Pulse Oximeter With Mars - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K000794 |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K893643 |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V 515B with RS-232 Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K893643 |
| Apr 8, 2010 | Philips Healthcare Inc. French 100-120V 515B Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K893643 |
| Apr 8, 2010 | Philips Healthcare Inc. 515B Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K893643 |
| Apr 8, 2010 | Philips Healthcare Inc. Span 100-120V 520A - OxyPleth Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K913516 |
| Apr 8, 2010 | Philips Healthcare Inc. Japanese 100-120V Oxypleth - 520A Pulse Oximeter- Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K913516 |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V Oxypleth - 520A Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | K913516 |
| Apr 8, 2010 | Philips Healthcare Inc. Refurbished Tidal Wave SP 715, Refurbished, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/rec Terminated |
DQA | K032971 |
| Apr 8, 2010 | Philips Healthcare Inc. Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips product.
Used to provide spirometric, carbon dioxide and pulse oximetry monitoring during general anesthesia and in the intensive c Terminated |
DQA | K032971 |
| Apr 8, 2010 | Philips Healthcare Inc. Cosmo Model 7100 SP02 & ETC02 Monitor, Refurbished, Respironics/Philips product.
Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monit Terminated |
DQA | K920379 |
| Apr 8, 2010 | Philips Healthcare Inc. Japanese TidalWave SP 715, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the int Terminated |
DQA | K032971 |
| Apr 8, 2010 | Philips Healthcare Inc. Tidal Wave Sp Model 715, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the inten Terminated |
DQA | K032971 |
| Apr 8, 2010 | Philips Healthcare Inc. Japanese TidalWave SP 710, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the int Terminated |
DQA | K032971 |
| Apr 8, 2010 | Philips Healthcare Inc. TidalWave SP 710, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive ca Terminated |
DQA | K032971 |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips products.
Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring envi Terminated |
DQA | K920379 |
| Apr 8, 2010 | Philips Healthcare Inc. Cosmo - Model 7100 SP02 & ETC02 Monitor, Respironics./Philips product.
Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring envi Terminated |
DQA | K920379 |
| Apr 8, 2010 | Philips Healthcare Inc. Sharn TidalGuard SP 710V, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the inte Terminated |
DQA | K032971 |
| Mar 2, 2010 | Smiths Medical PM, Inc. BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E. Main St., Westfield, PA 16950). Terminated |
DQA | K020350 |
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