RESONEA, INC.

Address:9383 E Bahia Dr Ste 205,Scottsdale,AZ,85260,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ventilatory Effort Recorder (MNR) (1)

Premarket Exempt

Clear

DROWZLE Pro - 00860004872405 Catalog Number :

Device Description : DROWZLE PRO is indicated to record a patient’s respiratory pattern during sleep DROWZLE PRO is indicated to record a patient’s respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stastages, limb movements, or EEG activity are required

Device Class : 2

Duns Number: 079132539

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

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