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Respironics Inc., Sleep & Home Respiratory Group

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K092835 COMFORTGEL NASAL MASKBZD2010-02-12 View
510(k) K092648 RESPIRONICS PERFORMAX SE TOTAL FACE MASKCBK2009-12-18 View
510(k) K090539 BIPAP AUTOSV ADVANCEDMNS2009-10-30 View
510(k) K091191 GAS TRANSFILLCAW2009-10-23 View
510(k) K091843 COMFORT TWIN NASAL MASKBZD2009-09-10 View
510(k) K091066 COMFORT TWIN NASAL MASKBZD2009-09-03 View
510(k) K091319 REMSTAR AUTO A-FLEXBZD2009-08-03 View
510(k) K090484 ALICE PDXMNR2009-06-26 View
510(k) K091271 RESPIRONICS PERFORMAX TOTAL FACE MASKBZD2009-05-29 View
510(k) K090243 REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEMBZD2009-05-08 View
510(k) K083526 TRILOGY 100 VENTILATORCBK2009-03-13 View
510(k) K090248 BIPAP AUTOSVMNS2009-03-04 View
510(k) K082866 REVOLUTIONFULL FACE MASKBZD2009-01-30 View
510(k) K083874 GALAXYMNR2009-01-26 View
510(k) K073600 COMFORTGEL FULL FACE MASKBZD2008-04-25 View
510(k) K072592 PERFORMAX TOTAL FACE MASKBZD2007-12-19 View
510(k) K072588 PERFORMAX SE TOTAL FACE MASKCBK2007-12-18 View
510(k) K071509 BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEMMNS2007-08-08 View
510(k) K070180 WALLABY 4LBI2007-05-18 View
510(k) K070328 BIPAP SYNCHRONY WITH AVAPSMNS2007-05-08 View
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