Respironics, Inc. - FDA 510(k) Cleared Devices
172
Total
168
Cleared
0
Denied
172 devices
Cleared
Sep 08, 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
Anesthesiology
28d
Cleared
Jun 22, 2000
BIPAP DUET LX BI-LEVEL SYSTEM
Anesthesiology
86d
Cleared
May 12, 2000
ESPIRT
Anesthesiology
28d
Cleared
Mar 20, 2000
BIPAP SYNCHRONY HC
Anesthesiology
236d
Cleared
Nov 10, 1999
RESPIRONICS TOTAL FACE MASK
Anesthesiology
68d
Cleared
Oct 27, 1999
ARIA LX CPAP SYSTEM
Anesthesiology
23d
Cleared
Oct 27, 1999
VIRTUOSO LX SMART CPAP SYSTEM
Anesthesiology
15d
Cleared
Aug 13, 1999
MONARCH II MINI MASK
Anesthesiology
31d
Cleared
May 28, 1999
REUSABLE CONTOUR II NASAL MASK
Anesthesiology
15d
Cleared
May 24, 1999
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
Anesthesiology
90d
Cleared
May 19, 1999
BIPAP HARMONY S/T, MODEL 1001445
Anesthesiology
161d
Cleared
May 17, 1999
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
General Hospital
6d
Cleared
Apr 19, 1999
SMARTRECORDER, MODEL 2500
Anesthesiology
88d
Cleared
Mar 04, 1999
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
Chemistry
183d
Cleared
Nov 12, 1998
ESPRIT VENTILATOR
Anesthesiology
233d
Cleared
Nov 03, 1998
BIPAP VISION VENTILATORY SUPPORT
Anesthesiology
111d
Cleared
Oct 05, 1998
BROWSER (EVENT SOFTWARE) MODEL # 4500E
Anesthesiology
75d
Cleared
May 14, 1998
STARDUST
Anesthesiology
211d
Cleared
Jan 26, 1998
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
Ear, Nose, Throat
108d
Cleared
Oct 28, 1997
CRICKET 2000 RECORDING PULSE OXIMETER
Anesthesiology
90d
Cleared
Apr 18, 1997
QUARTET CLINICAL SYSTEM
Anesthesiology
212d
Cleared
Feb 14, 1997
OASIS HUMIDIFIER
Anesthesiology
86d
Cleared
Jan 30, 1997
BIPAP DUET SYSTEM
Anesthesiology
90d
Cleared
Dec 20, 1996
BIPAP S/T-D 30 SYSTEM
Anesthesiology
396d
Cleared
Dec 05, 1996
WHISPER SWIVEL II EXHALATION PORT
Anesthesiology
181d
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