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U.S. Department of Health and Human Services

510(k) Premarket Notification
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41 to 50 of 167 Results
ProductCode: MNR Decision Date To: 09/26/2021
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510(K)
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watch-pat200u ITAMAR MEDICAL, LTD. K161579 02/24/2017
menai system ResMed Ltd K160836 12/15/2016
apnea risk evaluation system (ares), model 620 Watermark Medical K160499 04/24/2017
matrx plus Zephyr Sleep Technologies K163665 05/05/2017
sleepimage system MyCardio, LLC dba SleepImage. K163696 10/13/2017
audicor ca300/cc100 analyzer with sdb INOVISE MEDICAL, INC. K151433 03/18/2016
snoresounds APPIAN MEDICAL, INC. K150102 11/05/2015
watch-pat200u ITAMAR MEDICAL, LTD. K153070 07/26/2016
capnostream 35 portable respiratory monitor ORIDION MEDICAL 1987 LTD. K150272 07/17/2015
binaps nasal airflow and snore transducer; thermisense oral/nasal thermal airflow sensor with airflow pressure cannulas, nasal and oral/nasal Salter Labs K151874 04/15/2016
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