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) |
|---|---|---|---|
| Jan 13, 2010 | General Electric Medical Systems Information Technology GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software) Terminated |
DQA | K980299 |
| Jun 28, 2009 | Dixtal Medical, Inc. Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style
Catalog #: 6480-25.
The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of t Terminated |
DQA | K913516 |
| Oct 10, 2008 | Philips Medical Systems M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to aut Terminated |
DQA | K041674 |
| Sep 18, 2008 | Philips Medical Systems Philips Telemonitoring System Software (M3811B) used with
Philips Telemonitoring System (M3810B)
Revision: B.02.07
Prescriptive medical device used to automatically collect and transmit medical info Terminated |
DQA | K041674 |
| Aug 15, 2008 | Smiths Medical PM, Inc. BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. Terminated |
DQA | K020350 |
| Aug 6, 2008 | International Technidyne Corp. International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-220 Terminated |
DQA | K922075 |
| Aug 6, 2008 | International Technidyne Corp. International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220 Terminated |
DQA | K922075 |
| Jun 26, 2008 | Kentec Medical Inc Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614 Terminated |
DQA | K970098 |
| Apr 11, 2008 | Nonin Medical, Inc Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA Terminated |
DQA | K002690 K050056 |
| Nov 28, 2007 | Oridion Capnography Inc Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical Terminated |
DQA | K060065 |
| Nov 28, 2007 | Oridion Capnography Inc Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical Terminated |
DQA | K060065 |
| Oct 31, 2007 | Medtronic, Inc. Medtronic Export XT Aspiration Catheter, 6F (US)
Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US) Terminated |
DQA | K061958 |
| Sep 21, 2007 | Smiths Medical PM, Inc. BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc Terminated |
DQA | K981939 |
| Dec 19, 2006 | Smiths Medical PM, Inc. BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system fea Terminated |
DQA | K981939 |
| Nov 16, 2006 | Philips Medical Systems M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002 Terminated |
DQA | K033715 |
| Nov 16, 2006 | Philips Medical Systems M3001A Philips Multi Measurement Server (MMS) Terminated |
DQA | K033715 |
| Sep 12, 2006 | Philips Medical Systems IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system.
Model: M3001A Terminated |
DQA | K033715 |
| Mar 18, 2006 | Masimo Corporation Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter Terminated |
DQA | K042536 |
| Jun 25, 2005 | Masimo Corporation Radical Handheld Pulse Oximeter Terminated |
DQA | K992340 |
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor brand Pulse Oximeter, model N-395,
Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A. Terminated |
DQA | K993637 |
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor brand OxiMax Pulse Oximeter, model number N-595
Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A. Terminated |
DQA | K012891 |
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295,
Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A. Terminated |
DQA | K973147 |
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland, Oxismart,
Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A. Terminated |
DQA | K972837 |
| Aug 10, 2004 | Welch Allyn Protocol, Inc Welch Allyn Vital Signs Monitor 5300 Series 300
Part numbers 007-0098-00 through 007-0159-00 Terminated |
DQA | None listed |
| Jul 20, 2004 | Respironics Novametrix, Inc. Model 509M Pulse Oximetry Interface Module
Software versions 2.0 or 2.5 Terminated |
DQA | K000794 K032755 +1 |
| Jul 20, 2004 | Minolta Corp Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accur Terminated |
DQA | K010413 |
| Jul 20, 2004 | Minolta Corp Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 Terminated |
DQA | K010413 |
| Mar 5, 2003 | Datex-Ohmeda Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT) Terminated |
DQA | K010463 K011670 |
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