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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 164 Results
ProductCode: MNR Decision Date To: 09/26/2021
 
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nomadair pmu810 Neurotronics, Inc. K220631 07/15/2022
watchpat one (wp1) Itamar Medical, LTD K223675 01/06/2023
bresodx1 Bresotec Inc K220012 12/21/2022
anne sleep Sibel Inc. K220095 07/11/2022
nightowl Ectosense nv K220028 02/24/2022
watchpat300 (wp300) Itamar Medical, Ltd K222331 09/14/2022
acupebble sa Acurable Limited K210480 07/06/2021
nightowl Ectosense nv K213463 12/16/2021
sleepcheckrx ResApp Health K213360 07/05/2022
onera sleep test system (onera sts) Onera B.V. K210593 04/06/2022
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