RESMED SA

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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

Device, Jaw Repositioning (LQZ) (1)

Premarket Exempt

Clear

NARVAL CC - 03760287780022 Catalog Number :

Device Description : The Narval CC mandibular repositioning device is a removable intraoral device us The Narval CC mandibular repositioning device is a removable intraoral device used for the treatment of snoring and Obstructive Sleep Apnea (OSA). Similarly to other mandibular repositioning device, the Narval CC functions by advancing the lower jaw (mandible) in a forward position during sleep. This acts to increase the patient's pharyngeal space, improving their ability to exchange air and reducing their tendency to snore.

Device Class : 2

Duns Number: 383473204

Premarket Exempt : No

Product Code : LQZ

Prescription Use : Yes

Device Count : 1

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