Respironics Inc., Sleep & Home Respiratory Group - FDA 510(k) Cleared...
21
Total
21
Cleared
0
Denied
20 devices
Cleared
Feb 12, 2010
COMFORTGEL NASAL MASK
Anesthesiology
150d
Cleared
Dec 18, 2009
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
Anesthesiology
112d
Cleared
Oct 30, 2009
BIPAP AUTOSV ADVANCED
Anesthesiology
245d
Cleared
Oct 23, 2009
GAS TRANSFILL
Anesthesiology
183d
Cleared
Sep 10, 2009
COMFORT TWIN NASAL MASK
Anesthesiology
80d
Cleared
Sep 03, 2009
COMFORT TWIN NASAL MASK
Anesthesiology
142d
Cleared
Aug 03, 2009
REMSTAR AUTO A-FLEX
Anesthesiology
90d
Cleared
Jun 26, 2009
ALICE PDX
Anesthesiology
121d
Cleared
May 29, 2009
RESPIRONICS PERFORMAX TOTAL FACE MASK
Anesthesiology
29d
Cleared
May 08, 2009
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
Anesthesiology
95d
Cleared
Mar 13, 2009
TRILOGY 100 VENTILATOR
Anesthesiology
105d
Cleared
Mar 04, 2009
BIPAP AUTOSV
Anesthesiology
30d
Cleared
Jan 30, 2009
REVOLUTIONFULL FACE MASK
Anesthesiology
123d
Cleared
Jan 26, 2009
GALAXY
Anesthesiology
28d
Cleared
Apr 25, 2008
COMFORTGEL FULL FACE MASK
Anesthesiology
126d
Cleared
Dec 19, 2007
PERFORMAX TOTAL FACE MASK
Anesthesiology
96d
Cleared
Dec 18, 2007
PERFORMAX SE TOTAL FACE MASK
Anesthesiology
95d
Cleared
Aug 08, 2007
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
Anesthesiology
65d
Cleared
May 08, 2007
BIPAP SYNCHRONY WITH AVAPS
Anesthesiology
92d
Cleared
Mar 09, 2007
REMSTAR AFLEX CPAP SYSTEM
Anesthesiology
73d