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U.S. Department of Health and Human Services

510(k) Premarket Notification
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21 to 30 of 167 Results
ProductCode: MNR Decision Date To: 09/26/2021
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maxxi flow sensor Neurovirtual USA, INC. K201495 12/14/2020
watchpat200u (wp200u) Itamar Medical, Ltd. K203839 03/21/2022
nightowl Ectosense nv K191031 03/06/2020
maxxi snore sensor Neurovirtual USA, INC. K191095 01/16/2020
apneatrak Cadwell Industries, Inc. K192624 02/20/2020
matrx plus Zephyr Sleep Technologies K191925 10/29/2019
serenity piezo sensor, serenity thermocouple sensor Neurotronics, Inc. K181709 11/16/2018
disposable breathsensor adult, disposable breathsensor small adult / child, disposable breathsensor preemie, disposable breathsensor infant Embla Systems K180001 09/27/2019
watch-pat300 Itamar Medical, Ltd. K180775 08/17/2018
watchpat one Itamar Medical, Ltd. K183559 06/05/2019
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