Respironics, Inc. - FDA 510(k) Cleared Devices
172
Total
168
Cleared
0
Denied
154 devices
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
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
Cleared
Nov 14, 1996
PRESSURE VALVE
Anesthesiology
87d
Cleared
Sep 30, 1996
VIRTUOSO SMART CPAP SYSTEM
Anesthesiology
406d
Cleared
Aug 15, 1996
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
Anesthesiology
90d
Cleared
Jul 29, 1996
BIPAP MODEL S/T-D
Anesthesiology
496d
Cleared
Jul 18, 1996
SOLO CPAP SYSTEM
Anesthesiology
83d
Cleared
Jun 26, 1996
MAESTRO CLINICAL REMOTE CONTROL
Anesthesiology
268d
Cleared
Mar 01, 1996
HUMIDIFIER
Anesthesiology
462d
Cleared
Jan 31, 1996
RESPIRONICS MONARCH MINI MASK
Anesthesiology
422d
Cleared
Jan 31, 1996
GEL MASK
Anesthesiology
146d
Cleared
Jan 30, 1996
ARIA CPAP SYSTEM
Anesthesiology
266d
Cleared
Mar 29, 1995
SPECTRUM(TM) MASK
Anesthesiology
464d
Cleared
Jan 05, 1995
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
Anesthesiology
462d
Cleared
May 06, 1994
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
Anesthesiology
87d
Cleared
Dec 14, 1993
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
Anesthesiology
104d
Cleared
Sep 14, 1993
NASAL/ORAL MASK
Anesthesiology
313d
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