Medical Device Manufacturer · US , Murrysville , PA

Respironics Inc., Sleep & Home Respiratory Group - FDA 510(k) Cleared...

21 submissions · 21 cleared · Since 2007
21
Total
21
Cleared
0
Denied

Respironics Inc., Sleep & Home Respiratory Group has 21 FDA 510(k) cleared anesthesiology devices. Based in Murrysville, US.

Historical record: 21 cleared submissions from 2007 to 2010.

Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Respironics Inc., Sleep & Home Respiratory Group
21 devices
1-21 of 21
Cleared Feb 12, 2010
COMFORTGEL NASAL MASK
K092835 · BZD
Anesthesiology · 150d
Cleared Dec 18, 2009
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
K092648 · CBK
Anesthesiology · 112d
Cleared Oct 30, 2009
BIPAP AUTOSV ADVANCED
K090539 · MNS
Anesthesiology · 245d
Cleared Oct 23, 2009
GAS TRANSFILL
K091191 · CAW
Anesthesiology · 183d
Cleared Sep 10, 2009
COMFORT TWIN NASAL MASK
K091843 · BZD
Anesthesiology · 80d
Cleared Sep 03, 2009
COMFORT TWIN NASAL MASK
K091066 · BZD
Anesthesiology · 142d
Cleared Aug 03, 2009
REMSTAR AUTO A-FLEX
K091319 · BZD
Anesthesiology · 90d
Cleared Jun 26, 2009
ALICE PDX
K090484 · MNR
Anesthesiology · 121d
Cleared May 29, 2009
RESPIRONICS PERFORMAX TOTAL FACE MASK
K091271 · BZD
Anesthesiology · 29d
Cleared May 08, 2009
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
K090243 · BZD
Anesthesiology · 95d
Cleared Mar 13, 2009
TRILOGY 100 VENTILATOR
K083526 · CBK
Anesthesiology · 105d
Cleared Mar 04, 2009
BIPAP AUTOSV
K090248 · MNS
Anesthesiology · 30d
Cleared Jan 30, 2009
REVOLUTIONFULL FACE MASK
K082866 · BZD
Anesthesiology · 123d
Cleared Jan 26, 2009
GALAXY
K083874 · MNR
Anesthesiology · 28d
Cleared Apr 25, 2008
COMFORTGEL FULL FACE MASK
K073600 · BZD
Anesthesiology · 126d
Cleared Dec 19, 2007
PERFORMAX TOTAL FACE MASK
K072592 · BZD
Anesthesiology · 96d
Cleared Dec 18, 2007
PERFORMAX SE TOTAL FACE MASK
K072588 · CBK
Anesthesiology · 95d
Cleared Aug 08, 2007
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
K071509 · MNS
Anesthesiology · 65d
Cleared May 18, 2007
WALLABY 4
K070180 · LBI
General Hospital · 119d
Cleared May 08, 2007
BIPAP SYNCHRONY WITH AVAPS
K070328 · MNS
Anesthesiology · 92d
Cleared Mar 09, 2007
REMSTAR AFLEX CPAP SYSTEM
K063830 · BZD
Anesthesiology · 73d
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