MNR · Class II · 21 CFR 868.2375

FDA Product Code MNR: Ventilatory Effort Recorder

Leading manufacturers include Itamar Medical , Ltd., Huxley Medical and Ectosense NV.

161
Total
161
Cleared
200d
Avg days
1995
Since
161 devices
25–48 of 161
Cleared Sep 14, 2022
WatchPAT300 (WP300)
K222331
Itamar Medical , Ltd.
Anesthesiology · 43d
Cleared Jul 11, 2022
ANNE Sleep
K220095
Sibel, Inc.
Anesthesiology · 180d
Cleared Jul 05, 2022
SleepCheckRx
K213360
Resapp Health
Anesthesiology · 266d
Cleared Apr 06, 2022
Onera Sleep Test System (Onera STS)
K210593
Onera B.V.
Neurology · 401d
Cleared Mar 21, 2022
WatchPAT200U (WP200U)
K203839
Itamar Medical , Ltd.
Anesthesiology · 446d
Cleared Feb 24, 2022
NightOwl
K220028
Ectosense NV
Anesthesiology · 50d
Cleared Dec 21, 2021
Wesper Lab
K203343
Wesper, Inc.
Anesthesiology · 403d
Cleared Dec 16, 2021
NightOwl
K213463
Ectosense NV
Anesthesiology · 50d
Cleared Jul 06, 2021
AcuPebble SA
K210480
Acurable Limited
Anesthesiology · 137d
Cleared Dec 14, 2020
Maxxi Flow Sensor
K201495
Neurovirtual USA, Inc.
Anesthesiology · 192d
Cleared Aug 24, 2020
MATRx plus
K200695
Zephyr Sleep Technologies
Dental · 160d
Cleared Jul 22, 2020
Rubicon SA System
K200654
Dymedix Diagnostics, Inc.
Anesthesiology · 132d
Cleared Mar 06, 2020
NightOwl
K191031
Ectosense NV
Anesthesiology · 323d
Cleared Jan 16, 2020
Maxxi Snore Sensor
K191095
Neurovirtual USA, Inc.
Anesthesiology · 266d
Cleared Oct 29, 2019
MATRx Plus
K191925
Zephyr Sleep Technologies
Dental · 103d
Cleared Oct 18, 2019
SomnaPatch
K183625
Respironics, Inc.
Anesthesiology · 296d
Cleared Sep 27, 2019
Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
K180001
Embla Systems
Anesthesiology · 633d
Cleared Aug 14, 2019
SleepImage System
K182618
Mycardio, LLC Dba Sleepimage.
Anesthesiology · 324d
Cleared Jul 14, 2019
DROWZLE
K173974
Resonea, Inc.
Anesthesiology · 562d
Cleared Jun 24, 2019
Maxxi Rip Sensor
K171304
Neurovirtual USA, Inc.
Anesthesiology · 782d
Cleared Jun 05, 2019
WatchPAT ONE
K183559
Itamar Medical , Ltd.
Anesthesiology · 167d
Cleared Mar 01, 2019
XactTrace Single Use Respiratory Effort Belt System
K173793
Embla Systems
Anesthesiology · 442d
Cleared Nov 21, 2018
MATRx Plus
K181996
Zephyr Sleep Technologies
Anesthesiology · 118d
Cleared Aug 17, 2018
Watch-PAT300
K180775
Itamar Medical , Ltd.
Anesthesiology · 147d