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 Masimo Corp..
726
Total
726
Cleared
162d
Avg days
1978
Since
726 devices
Cleared
Aug 01, 2002
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
Ge Medical Systems Information Technologies
Anesthesiology
27d
Cleared
Jul 23, 2002
INFINITY MICRO2+
Siemens Medical Solutions USA, Inc.
Anesthesiology
340d
Cleared
Jul 17, 2002
PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
Philips Medical Systems
Anesthesiology
48d
Cleared
Jun 19, 2002
OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR
Nellcor Puritan Bennett, Inc.
Anesthesiology
76d
Cleared
May 08, 2002
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
Nellcor Puritan Bennett, Inc.
Anesthesiology
34d
Cleared
Mar 26, 2002
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
Datex-Ohmeda
Anesthesiology
41d
Cleared
Mar 07, 2002
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)
Nellcor Puritan Bennett, Inc.
Anesthesiology
191d
Cleared
Jan 25, 2002
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
Medical Data Electronics
Anesthesiology
28d
Cleared
Jan 03, 2002
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
Nonin Medical, Inc.
Anesthesiology
90d
Cleared
Dec 20, 2001
FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
Fukuda Denshi USA, Inc.
Anesthesiology
80d
Cleared
Dec 11, 2001
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
Masimo Corp.
Anesthesiology
27d
Cleared
Oct 03, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES
Masimo Corp.
Anesthesiology
27d
Cleared
Aug 09, 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
Hitachi Medical Systems America, Inc.
Anesthesiology
100d
Cleared
Jul 11, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
Masimo Corp.
Anesthesiology
28d
Cleared
Jun 26, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
Datex-Ohmeda
Anesthesiology
27d
Cleared
Jun 08, 2001
MEDLEY SP02 MODULE, MODEL 8220
Alaris Medical Systems, Inc.
Anesthesiology
67d
Cleared
Apr 25, 2001
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
Novametrix Medical Systems, Inc.
Anesthesiology
69d
Cleared
Mar 15, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
Datex-Ohmeda, Inc.
Anesthesiology
27d
Cleared
Mar 06, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
Masimo Corp.
Anesthesiology
22d
Cleared
Nov 08, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
Masimo Corp.
Anesthesiology
29d
Cleared
Nov 08, 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
Masimo Corp.
Anesthesiology
22d
Cleared
Oct 18, 2000
SOLAR SPO2 MODULE WITH MASIMO SET
General Electric Medical Systems Information Techn
Anesthesiology
26d
Cleared
Oct 11, 2000
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
Nonin Medical, Inc.
Anesthesiology
43d
Cleared
Oct 06, 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER
Masimo Corp.
Anesthesiology
15d