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Respironics, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories5
Latest FDA decision2024-12-30
TypeNumberDevice NameCodeDateActions
510(k) K243394 AF531 Oro-Nasal SE Face MaskCBK2024-12-30 View
510(k) K231313 Therapy Mask 3100 NC/SPBZD2023-07-28 View
510(k) K210844 DreamWear Silicone Pillows MaskBZD2021-08-24 View
510(k) K210386 Magneto Nasal MaskBZD2021-07-12 View
510(k) K202142 Sleepware G3OLZ2020-10-29 View
510(k) K201439 Ventilator, Non-continuous (Respirator)BZD2020-09-25 View
510(k) K200480 DreamStation 2 System, DreamStation 2 Advanced SystemBZD2020-07-10 View
510(k) K183226 Care Orchestrator EssenceBZD2019-10-18 View
510(k) K183625 SomnaPatchMNR2019-10-18 View
510(k) K181166 Trilogy EvoCBK2019-07-18 View
510(k) K181170 Trilogy Evo UniversalCBK2019-07-18 View
510(k) K181053 Care OrchestratorBZD2019-01-04 View
510(k) K161411 Care Cycle Connect ApplicationMOD2017-02-17 View
510(k) K151120 Simple T Pediatric Nasal MaskBZD2016-04-15 View
510(k) K152356 SapphireBZD2016-01-08 View
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