2Z Medical

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Filters

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

Pillow,Cervical(For Mild Sleep Apnea) (MYB) (1)

Premarket Exempt

Clear

Zzoma - 00863826000315 Catalog Number :

Device Description : The Zzoma Positional Device is an FDA-cleared positional medical device for the The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA).

Device Class : 2

Duns Number: 829477228

Premarket Exempt : No

Product Code : MYB

Prescription Use : Yes

Device Count : 1

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