FDA 510(k) Applications Submitted by ZITA 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


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