AIRWAY TECHNOLOGIES, LLC

AIRWAY TECHNOLOGIES, LLC

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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

Device, Anti-Snoring (LRK) (4) Ventilator, Non-Continuous (Respirator) (BZD) (2)

Premarket Exempt

No Yes

Clear

MyTAP oral appliance - 00851085006001 Catalog Number :

Device Class :

Duns Number: 963501148

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

MyTAP PAP Nasal Pillow Mask - 00851085006018 Catalog Number :

Device Class : 2

Duns Number: 963501148

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

MyTAP PAP Nasal Pillow Mask no headgear - 00851085006025 Catalog Number :

Device Class : 2

Duns Number: 963501148

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

TAP-1 components - 00851085006032 Catalog Number :

Device Class :

Duns Number: 963501148

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

TAP-3 components - 00851085006049 Catalog Number :

Device Class :

Duns Number: 963501148

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

TAP-3 Elite components - 00851085006056 Catalog Number :

Device Class :

Duns Number: 963501148

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

dreamTAP components - 00851085006063 Catalog Number :

Device Class :

Duns Number: 963501148

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

TAP-1 oral appliance - 00851085006070 Catalog Number :

Device Class : 2

Duns Number: 963501148

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

TAP-3 oral appliance - 00851085006087 Catalog Number :

Device Class : 2

Duns Number: 963501148

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

TAP-3 Elite oral appliance - 00851085006094 Catalog Number :

Device Class : 2

Duns Number: 963501148

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

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