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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 164 Results
ProductCode: MNR Decision Date To: 09/26/2021
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nightowl Ectosense nv K213463 12/16/2021
acupebble sa Acurable Limited K210480 07/06/2021
maxxi flow sensor Neurovirtual USA, INC. K201495 12/14/2020
ventilator, non-continuous (respirator) Respironics, Inc. K201439 09/25/2020
tempus pro patient monitor Remote Diagnostic Technologies Limited K201746 09/18/2020
matrx plus Zephyr Sleep Technologies K200695 08/24/2020
somnoscreen plus Somnomedics GmbH K201054 08/12/2020
rubicon sa system Dymedix Diagnostics, Inc. K200654 07/22/2020
capnostream 35 portable respiratory monitor Oridion Medical 1987 Ltd. K200594 04/27/2020
nightowl Ectosense nv K191031 03/06/2020
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