NOVASOM, INC.

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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

Ventilatory Effort Recorder (MNR) (1)

Premarket Exempt

Clear

AccuSom - 00860512000208 Catalog Number :

Device Description : Sleep apnea diagnosic device

Device Class : 2

Duns Number: 808379150

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

AccuSom - 00860512000215 Catalog Number :

Device Description : Chain of Custody Patient Interface Dongle

Device Class :

Duns Number: 808379150

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

AccuSom - 00860512000222 Catalog Number :

Device Description : Breath Sensor

Device Class :

Duns Number: 808379150

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

AccuSom - 00860512000239 Catalog Number :

Device Description : Device box

Device Class :

Duns Number: 808379150

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

AccuSom - 00860512000246 Catalog Number :

Device Description : Chain of Custody Disposable Sensors

Device Class :

Duns Number: 808379150

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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