ClearanceBrief
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)
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Top companies in DQA

DateFirm and productCodeLinked 510(k)
Jan 13, 2010General Electric Medical Systems Information Technology
GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software)
Terminated
DQAK980299
Jun 28, 2009Dixtal 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
DQAK913516
Oct 10, 2008Philips 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
DQAK041674
Sep 18, 2008Philips 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
DQAK041674
Aug 15, 2008Smiths 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
DQAK020350
Aug 6, 2008International Technidyne Corp.
International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-220
Terminated
DQAK922075
Aug 6, 2008International Technidyne Corp.
International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
Terminated
DQAK922075
Jun 26, 2008Kentec 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
DQAK970098
Apr 11, 2008Nonin Medical, Inc
Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA
Terminated
DQAK002690
K050056
Nov 28, 2007Oridion Capnography Inc
Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical
Terminated
DQAK060065
Nov 28, 2007Oridion Capnography Inc
Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical
Terminated
DQAK060065
Oct 31, 2007Medtronic, Inc.
Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
Terminated
DQAK061958
Sep 21, 2007Smiths 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
DQAK981939
Dec 19, 2006Smiths 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
DQAK981939
Nov 16, 2006Philips 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
DQAK033715
Nov 16, 2006Philips Medical Systems
M3001A Philips Multi Measurement Server (MMS)
Terminated
DQAK033715
Sep 12, 2006Philips Medical Systems
IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A
Terminated
DQAK033715
Mar 18, 2006Masimo Corporation
Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter
Terminated
DQAK042536
Jun 25, 2005Masimo Corporation
Radical Handheld Pulse Oximeter
Terminated
DQAK992340
Mar 30, 2005Nellcor 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
DQAK993637
Mar 30, 2005Nellcor 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
DQAK012891
Mar 30, 2005Nellcor 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
DQAK973147
Mar 30, 2005Nellcor 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
DQAK972837
Aug 10, 2004Welch Allyn Protocol, Inc
Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00
Terminated
DQANone listed
Jul 20, 2004Respironics Novametrix, Inc.
Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5
Terminated
DQAK000794
K032755 +1
Jul 20, 2004Minolta 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
DQAK010413
Jul 20, 2004Minolta 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
DQAK010413
Mar 5, 2003Datex-Ohmeda
Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)
Terminated
DQAK010463
K011670

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