FDA 510(k) Applications Submitted by RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K082866 |
09/29/2008 |
REVOLUTIONFULL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K091271 |
04/30/2009 |
RESPIRONICS PERFORMAX TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K083874 |
12/29/2008 |
GALAXY |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K072588 |
09/14/2007 |
PERFORMAX SE TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K072592 |
09/14/2007 |
PERFORMAX TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K070180 |
01/19/2007 |
WALLABY 4 |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K090243 |
02/02/2009 |
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K090248 |
02/02/2009 |
BIPAP AUTOSV |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K070328 |
02/05/2007 |
BIPAP SYNCHRONY WITH AVAPS |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K090484 |
02/25/2009 |
ALICE PDX |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K090539 |
02/27/2009 |
BIPAP AUTOSV ADVANCED |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K091066 |
04/14/2009 |
COMFORT TWIN NASAL MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K091191 |
04/23/2009 |
GAS TRANSFILL |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K091319 |
05/05/2009 |
REMSTAR AUTO A-FLEX |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K071509 |
06/04/2007 |
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K091843 |
06/22/2009 |
COMFORT TWIN NASAL MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K092648 |
08/28/2009 |
RESPIRONICS PERFORMAX SE TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K092835 |
09/15/2009 |
COMFORTGEL NASAL MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K083526 |
11/28/2008 |
TRILOGY 100 VENTILATOR |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K063830 |
12/26/2006 |
REMSTAR AFLEX CPAP SYSTEM |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K073600 |
12/21/2007 |
COMFORTGEL FULL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
|
|
