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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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whisper swivel ii exhalation port RESPIRONICS, INC. K962203 12/05/1996
virtuoso smart cpap system RESPIRONICS, INC. K953930 09/30/1996
virtuoso lx smart cpap system RESPIRONICS, INC. K993433 10/27/1999
ventilator, non-continuous (respirator) Respironics, Inc. K201439 09/25/2020
trublue nasal mask RESPIRONICS, INC. K110405 06/06/2011
total face mask RESPIRONICS, INC. K925920 07/21/1993
ti nasal mask RESPIRONICS, INC. K140980 02/10/2015
spectrum(tm) mask RESPIRONICS, INC. K936047 03/29/1995
spectrum reusable full face mask - size petite, small, medium, large RESPIRONICS, INC. K961915 08/15/1996
spectrum 2 reusable full face mask, model 1004884 and 1004876 RESPIRONICS, INC. K002465 09/08/2000
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