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U.S. Department of Health and Human Services

510(k) Premarket Notification
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61 to 70 of 167 Results
ProductCode: MNR Decision Date To: 09/26/2021
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snoring microphone, sm1 PRO-TECH, INC. K940015 01/11/1995
body position indicator, model bpi1 PRO-TECH, INC. K940013 05/04/1995
modification ez-1 system repiratory sensors PRO-TECH SERVICES, INC. K013905 04/22/2002
pressure transducer airflow sensor PRO-TECH SERVICES, INC. K982293 07/13/1998
portable sleep data recorder (psdr) PRO-TECH SERVICES, INC. K033402 06/30/2004
capnostream20p with ai/odi ORIDION MEDICAL 1987 LTD. K112368 07/19/2012
capnostream 35 portable respiratory monitor Oridion Medical 1987 Ltd. K200594 04/27/2020
capnostream 35 portable respiratory monitor ORIDION MEDICAL 1987 LTD. K150272 07/17/2015
capnostream20p with hifi c02 monitoring ORIDION MEDICAL 1987 LTD. K123690 08/05/2014
onera sleep test system (onera sts) Onera B.V. K210593 04/06/2022
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