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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 30 of 164 Results
ProductCode: MNR Decision Date To: 09/26/2021
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apneatrak Cadwell Industries, Inc. K192624 02/20/2020
maxxi snore sensor Neurovirtual USA, INC. K191095 01/16/2020
matrx plus Zephyr Sleep Technologies K191925 10/29/2019
somnapatch Respironics, Inc. K183625 10/18/2019
disposable breathsensor adult, disposable breathsensor small adult / child, disposable breathsensor preemie, disposable breathsensor infant Embla Systems K180001 09/27/2019
sleepimage system MyCardio, LLC dba SleepImage. K182618 08/14/2019
drowzle Resonea, Inc. K173974 07/14/2019
maxxi rip sensor Neurovirtual USA, INC. K171304 06/24/2019
watchpat one Itamar Medical, Ltd. K183559 06/05/2019
xacttrace single use respiratory effort belt system Embla Systems K173793 03/01/2019
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