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U.S. Department of Health and Human Services

510(k) Premarket Notification

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61 to 70 of 165 Results
ProductCode: MNR Decision Date To: 09/26/2021
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embletta mpr EMBLA SYSTEMS K122516 02/21/2013
audicor cpam with sdb (cardiopulmonary ambulatory monitor with sleep disordered breathing detection) INOVISE MEDICAL, INC. K120462 09/20/2012
capnostream20p with ai/odi ORIDION MEDICAL 1987 LTD. K112368 07/19/2012
apnea risk evaluation system (ares) ADVANCED BRAIN MONITORING, INC. K112514 01/09/2012
sleepstrip ii S.L.P LTD. K112822 12/27/2011
michele sleep scoring systems YOUNES SLEEP TECHNOLOGIES K112102 12/20/2011
mdrive EMBLA SYSTEMS K111742 08/31/2011
morpheus ox WIDEMED LTD K111314 08/31/2011
accusom NOVASOM, INC. K110486 08/12/2011
apnea risk evaluation system (ares) ADVANCED BRAIN MONITORING, INC. K111194 07/07/2011
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