Respironics, Inc. - FDA 510(k) Cleared Devices
172
Total
168
Cleared
0
Denied
172 devices
Cleared
Jul 21, 2004
EOCD
Anesthesiology
41d
Cleared
May 20, 2004
STARDUST II, MODEL 1011176
Anesthesiology
715d
Cleared
May 05, 2004
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
Anesthesiology
15d
Cleared
Mar 18, 2004
ALICE 5
Neurology
10d
Cleared
Mar 04, 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
Anesthesiology
175d
Cleared
Feb 19, 2004
C2 NASAL MASK
Anesthesiology
79d
Cleared
Feb 06, 2004
RESPIRONICS CUSTOM I ORAL APPLIANCE
Dental
58d
Cleared
Feb 06, 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
Dental
58d
Cleared
Jan 27, 2004
HEEL SNUGGLER, MODEL 99047
Physical Medicine
15d
Cleared
Jan 21, 2004
ESPRIT VENTILATOR, MODEL V1000
Anesthesiology
23d
Cleared
Oct 27, 2003
SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
Anesthesiology
84d
Cleared
Jul 30, 2003
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
Anesthesiology
63d
Cleared
Jun 24, 2003
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
Anesthesiology
47d
Cleared
Jan 24, 2003
H2 HEATED HUMIDIFIER
Anesthesiology
14d
Cleared
Jan 03, 2003
IMAGE3 SE DISPOSABLE FULL FACE MASK
Anesthesiology
105d
Cleared
Jun 19, 2002
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
Anesthesiology
13d
Cleared
Mar 20, 2002
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
Anesthesiology
9d
Cleared
Feb 28, 2002
RESPIRONICS HEATED HUMIDIFIER
Anesthesiology
199d
Cleared
Jan 29, 2002
REMSTAR AUTO CPAP SYSTEM
Anesthesiology
174d
Cleared
Dec 20, 2001
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
Anesthesiology
150d
Cleared
Jun 28, 2001
BIPAP PRO BI-LEVEL SYSTEM
Anesthesiology
24d
Cleared
Mar 29, 2001
REMSTAR PLUS CPAP SYSTEM
Anesthesiology
59d
Cleared
Mar 19, 2001
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
Chemistry
70d
Cleared
Feb 09, 2001
REMVIEW SLEEP RECORDER, MODEL 320
Neurology
88d
Cleared
Sep 08, 2000
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
Anesthesiology
190d
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