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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 61 Results
ProductCode: BZD Applicant: RESPIRONICS, INC. Decision Date To: 05/01/2024
 
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dreamwear silicone pillows mask Respironics, Inc. K210844 08/24/2021
magneto nasal mask Respironics, Inc. K210386 07/12/2021
ventilator, non-continuous (respirator) Respironics, Inc. K201439 09/25/2020
dreamstation 2 system, dreamstation 2 advanced system Respironics, Inc. K200480 07/10/2020
simple t pediatric nasal mask RESPIRONICS, INC. K151120 04/15/2016
af541 ee full face mask RESPIRONICS, INC. K150639 09/18/2015
ti nasal mask RESPIRONICS, INC. K140980 02/10/2015
revolution full face mask Respironics, Inc. K142554 01/09/2015
simple t youth nasal mask RESPIRONICS, INC. K140268 10/20/2014
bronchoscopy elbow RESPIRONICS, INC. K132168 11/20/2013
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