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U.S. Department of Health and Human Services

510(k) Premarket Notification
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121 to 130 of 167 Results
ProductCode: MNR Decision Date To: 09/26/2021
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apnoescreen pro, alpha screen pro ERICH JAEGER, INC. K000396 12/27/2000
sleepscreen/apnoescreen cardio ERICH JAEGER GMBH K021138 02/12/2003
embletta gold EMBLA SYSTEMS, INC. K073682 08/08/2008
disposable breathsensor adult, disposable breathsensor small adult / child, disposable breathsensor preemie, disposable breathsensor infant Embla Systems K180001 09/27/2019
mdrive EMBLA SYSTEMS K111742 08/31/2011
xacttrace single use respiratory effort belt system Embla Systems K173793 03/01/2019
embletta mpr EMBLA SYSTEMS K122516 02/21/2013
nightowl Ectosense nv K191031 03/06/2020
nightowl Ectosense nv K220028 02/24/2022
nightowl Ectosense nv K213463 12/16/2021
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