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U.S. Department of Health and Human Services

510(k) Premarket Notification

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31 to 40 of 164 Results
ProductCode: MNR Decision Date To: 09/26/2021
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matrx plus Zephyr Sleep Technologies K181996 11/21/2018
serenity piezo sensor, serenity thermocouple sensor Neurotronics, Inc. K181709 11/16/2018
watch-pat300 Itamar Medical, Ltd. K180775 08/17/2018
star 65 Skanray Technologies Pvt Ltd K172147 05/25/2018
positional sleep assessment system (posas) software Advanced Brain Monitoring K172799 03/09/2018
tempus pro patient monitor Remote Diagnostic Technologies Ltd. K173768 01/10/2018
zmachine synergy Consolidated Research of Richmond, Inc. dba General Sleep Co K172986 12/19/2017
sleepimage system MyCardio, LLC dba SleepImage. K163696 10/13/2017
matrx plus Zephyr Sleep Technologies K163665 05/05/2017
apnea risk evaluation system (ares), model 620 Watermark Medical K160499 04/24/2017
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