DQA · Class II · 21 CFR 870.2700

FDA Product Code DQA: Oximeter

Continuous oxygen saturation monitoring is a cornerstone of safe patient care across clinical settings. FDA product code DQA covers pulse oximeters and oximeter systems.

These devices use near-infrared light to non-invasively measure the oxygen saturation of hemoglobin in arterial blood, providing a continuous, real-time assessment of respiratory status. They are standard equipment in operating rooms, intensive care units, and emergency departments worldwide.

DQA devices are Class II medical devices, regulated under 21 CFR 870.2700 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Masimo Corporation, Nonin Medical, Inc. and Nellcor Puritan Bennett, Inc..

726
Total
726
Cleared
162d
Avg days
1978
Since
726 devices
241–264 of 726
Cleared Feb 20, 2004
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
K032979
Philips Medical Systems, Inc.
Anesthesiology · 149d
Cleared Feb 13, 2004
PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
K033715
Philips Medical Systems, Inc.
Anesthesiology · 79d
Cleared Nov 25, 2003
DRAEGER MICRO2+ AND MASIMO MINISAT
K032537
Draeger Medical Systems, Inc.
Anesthesiology · 99d
Cleared Oct 17, 2003
MODEL 3100 WRISTOX PULSE OXIMETER
K030668
Nonin Medical, Inc.
Anesthesiology · 228d
Cleared Jul 23, 2003
MODEL 9600, AVANT PULSE OXIMETER
K023044
Nonin Medical, Inc.
Anesthesiology · 314d
Cleared Jul 23, 2003
PICOSAT II SPO2 PULSE OXIMETRY MODULE
K030973
Philips Medical Systems
Anesthesiology · 117d
Cleared Jun 03, 2003
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640
Siemens Medical Solutions USA, Inc.
Anesthesiology · 95d
Cleared May 23, 2003
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
K030930
Nellcor Puritan Bennett, Inc.
Anesthesiology · 59d
Cleared Oct 08, 2002
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
K021955
Datex-Ohmeda, Inc.
Anesthesiology · 116d
Cleared Sep 26, 2002
ATLAS MONITOR, MODELS 200,210,220
K022084
Welch Allyn, Inc.
Anesthesiology · 91d
Cleared Sep 24, 2002
NELLCOR N-200 PULSE OXIMETER, MODEL N-200
K022819
Nellcor Puritan Bennett, Inc.
Anesthesiology · 29d
Cleared Sep 17, 2002
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506
K022163
Welch Allyn, Inc.
Anesthesiology · 76d
Cleared Sep 05, 2002
SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
K022766
Siemens Medical Solutions USA, Inc.
Anesthesiology · 15d
Cleared Aug 01, 2002
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
K022193
Ge Medical Systems Information Technologies
Anesthesiology · 27d
Cleared Jul 23, 2002
INFINITY MICRO2+
K012770
Siemens Medical Solutions USA, Inc.
Anesthesiology · 340d
Cleared Jul 17, 2002
PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
K021778
Philips Medical Systems
Anesthesiology · 48d
Cleared Jun 19, 2002
OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR
K021089
Nellcor Puritan Bennett, Inc.
Anesthesiology · 76d
Cleared May 08, 2002
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
K021090
Nellcor Puritan Bennett, Inc.
Anesthesiology · 34d
Cleared Mar 26, 2002
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
K020479
Datex-Ohmeda
Anesthesiology · 41d
Cleared Mar 07, 2002
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)
K012891
Nellcor Puritan Bennett, Inc.
Anesthesiology · 191d
Cleared Jan 03, 2002
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
K013319
Nonin Medical, Inc.
Anesthesiology · 90d
Cleared Dec 20, 2001
FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
K013273
Fukuda Denshi USA, Inc.
Anesthesiology · 80d
Cleared Aug 09, 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320
Hitachi Medical Systems America, Inc.
Anesthesiology · 100d
Cleared Jun 26, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
K011670
Datex-Ohmeda
Anesthesiology · 27d