FDA 510(k) Applications Submitted by ZITA A YURKO
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K050414 |
02/18/2005 |
PLIX |
RESPIRONICS, INC. |
K021845 |
06/05/2002 |
STARDUST II, MODEL 1011176 |
RESPIRONICS, INC. |
K092043 |
07/06/2009 |
BIPAP SYNCHRONY 2 |
RESPIRONICS, INC. |
K072592 |
09/14/2007 |
PERFORMAX TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K072588 |
09/14/2007 |
PERFORMAX SE TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K093416 |
11/02/2009 |
TRILOGY 200 VENTILATOR |
RESPIRONICS, INC. |
K030090 |
01/10/2003 |
H2 HEATED HUMIDIFIER |
RESPIRONICS, INC. |
K040044 |
01/12/2004 |
HEEL SNUGGLER, MODEL 99047 |
RESPIRONICS, INC. |
K070180 |
01/19/2007 |
WALLABY 4 |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K090248 |
02/02/2009 |
BIPAP AUTOSV |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K090243 |
02/02/2009 |
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM |
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 |
K040595 |
03/08/2004 |
ALICE 5 |
RESPIRONICS, INC. |
K020777 |
03/11/2002 |
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX |
RESPIRONICS, INC. |
K050759 |
03/24/2005 |
BIPAP AUTO |
RESPIRONICS, INC. |
K060919 |
04/04/2006 |
ACTICAL |
RESPIRONICS, INC. |
K091028 |
04/10/2009 |
OMNI 5 TOTAL O2 DELIVERY SYSTEM |
RESPIRONICS, INC. |
K061034 |
04/14/2006 |
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
K091066 |
04/14/2009 |
COMFORT TWIN NASAL MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K091112 |
04/17/2009 |
RESPIRONICS SLEEPEASY CPAP SYSTEM |
RESPIRONICS, INC. |
K041010 |
04/20/2004 |
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM |
RESPIRONICS, INC. |
K101130 |
04/22/2010 |
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK |
RESPIRONICS, INC. |
K101129 |
04/22/2010 |
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK |
RESPIRONICS, INC. |
K091191 |
04/23/2009 |
GAS TRANSFILL |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K081206 |
04/29/2008 |
HOMELOX |
RESPIRONICS, INC. |
K061256 |
05/04/2006 |
SMARTMONITOR 2PS |
RESPIRONICS, INC. |
K061261 |
05/05/2006 |
L4 OXYGEN CONCENTRATOR |
RESPIRONICS, INC. |
K091319 |
05/05/2009 |
REMSTAR AUTO A-FLEX |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K031460 |
05/08/2003 |
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM |
RESPIRONICS, INC. |
K031656 |
05/28/2003 |
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
K071509 |
06/04/2007 |
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K021861 |
06/06/2002 |
REMSTAR PRO WITH C-FLEX CPAP SYSTEM |
RESPIRONICS, INC. |
K091843 |
06/22/2009 |
COMFORT TWIN NASAL MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K081779 |
06/23/2008 |
GOLOX-93 |
RESPIRONICS, INC. |
K061870 |
07/03/2006 |
VITALSENSE XHR |
RESPIRONICS, INC. |
K032403 |
08/04/2003 |
SMARTMONITOR 2 PROFESSIONAL SERIES (PS) |
RESPIRONICS, INC. |
K052110 |
08/04/2005 |
M-SERIES PRO CPAP SYTEM |
RESPIRONICS, INC. |
K092648 |
08/28/2009 |
RESPIRONICS PERFORMAX SE TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K032834 |
09/11/2003 |
BIPAP PRO 2 BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
K052489 |
09/12/2005 |
ACTIHEART |
RESPIRONICS, INC. |
K092818 |
09/14/2009 |
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
K092835 |
09/15/2009 |
COMFORTGEL NASAL MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K052573 |
09/19/2005 |
STARDUST II |
RESPIRONICS, INC. |
K023135 |
09/20/2002 |
IMAGE3 SE DISPOSABLE FULL FACE MASK |
RESPIRONICS, INC. |
K072723 |
09/26/2007 |
RESPIRONICS GOLOX |
RESPIRONICS, INC. |
K072996 |
10/24/2007 |
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM |
RESPIRONICS, INC. |
K043006 |
11/01/2004 |
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 |
RESPIRONICS, INC. |
K063533 |
11/22/2006 |
BIPAP SYNCHRONY |
RESPIRONICS, INC. |
K063540 |
11/24/2006 |
BIPAP AUTOSV |
RESPIRONICS, INC. |
K083526 |
11/28/2008 |
TRILOGY 100 VENTILATOR |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K033759 |
12/02/2003 |
C2 NASAL MASK |
RESPIRONICS, INC. |
K053352 |
12/02/2005 |
COMFORTLITE NASAL MASK |
RESPIRONICS, INC. |
K033823 |
12/10/2003 |
RESPIRONICS CUSTOM II ORAL APPLIANCE |
RESPIRONICS, INC. |
K033822 |
12/10/2003 |
RESPIRONICS CUSTOM I ORAL APPLIANCE |
RESPIRONICS, INC. |
K063830 |
12/26/2006 |
REMSTAR AFLEX CPAP SYSTEM |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
K043607 |
12/30/2004 |
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX |
RESPIRONICS, INC. |
K073600 |
12/21/2007 |
COMFORTGEL FULL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
|
|