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U.S. Department of Health and Human Services

510(k) Premarket Notification
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51 to 60 of 167 Results
ProductCode: MNR Decision Date To: 09/26/2021
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capnostream 35 portable respiratory monitor ORIDION MEDICAL 1987 LTD. K150272 07/17/2015
s9 elouera RESMED CORP K140124 05/12/2014
sleepware g3 RESPIRONICS, INC. K142988 03/16/2015
somnotouch resp SOMNOMEDICS GMBH K140861 01/30/2015
apnealink air RESMED GERMANY INC. K143272 04/30/2015
somnolyzer 24x7 RESPIRONICS, INC. K131994 10/17/2013
apnealink pro RESMED GERMANY INC. K131932 11/08/2013
audicor cpam with sdb (accelerometer based) INOVISE MEDICAL, INC. K131883 04/11/2014
audicor cpam with sdb (single sensor) INOVISE MEDICAL, INC. K130660 10/11/2013
watch-pat200u (wp200u) ITAMAR MEDICAL LTD K133859 05/30/2014
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