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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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qdc-pro, and nox-rip NOX MEDICAL K124062 07/10/2013
capnostream20p with hifi c02 monitoring ORIDION MEDICAL 1987 LTD. K123690 08/05/2014
audicor cpam with sdb (cardiopulmonary ambulatory monitor with sleep disordered breathing detection) INOVISE MEDICAL, INC. K120462 09/20/2012
embletta mpr EMBLA SYSTEMS K122516 02/21/2013
apnea risk evaluation system (ares) ADVANCED BRAIN MONITORING, INC. K111194 07/07/2011
sleepstrip ii S.L.P LTD. K112822 12/27/2011
spacelabs pathfinder sl holter analyzer SPACELABS HEALTHCARE LTD. K110001 06/14/2011
apnea risk evaluation system (ares) ADVANCED BRAIN MONITORING, INC. K112514 01/09/2012
capnostream20p with ai/odi ORIDION MEDICAL 1987 LTD. K112368 07/19/2012
apnea risk evaluation system (ares) ADVANCED BRAIN MONITORING INC. K110705 04/14/2011
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