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

FDA 510(k) Regulatory Record - Respironics Inc., Sleep & Home Respiratory Group Anesthesiology ✕

20 devices

1-12 of 20

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

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

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

Anesthesiology · 30d