PROSOMNUS SLEEP TECHNOLOGIES

Address:5860 West Las Positas Blvd.,Pleasanton,CA,94588,US

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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) (3) Sleep Appliances With Patient Monitoring (PLC) (3)

Premarket Exempt

Clear

Prosomnus CA Sleep and Snore Device - 00863039000409 Catalog Number :

Device Class : 2

Duns Number: 075438768

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Prosomnus IA Monogram - 00863039000416 Catalog Number :

Device Description : Device for Obstructive Sleep Apnea iterative adjustment with patient comfort features

Device Class : 2

Duns Number: 075438768

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Prosomnus IA MicrO2 - 00863039000423 Catalog Number :

Device Description : Obstructive Sleep Apnea Device with twin mated posts

Device Class : 2

Duns Number: 075438768

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Prosomnus IA with Patient Monitoring - 00863039000430 Catalog Number :

Device Description : Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring

Device Class : 2

Duns Number: 075438768

Premarket Exempt : No

Product Code : PLC

Prescription Use : Yes

Device Count : 1

Prosomnus IA MicrO2 with Patient Monitoring - 00863039000447 Catalog Number :

Device Description : Obstructive Sleep Apnea Device with twin mated posts and Patient Monitoring

Device Class : 2

Duns Number: 075438768

Premarket Exempt : No

Product Code : PLC

Prescription Use : Yes

Device Count : 1

Prosomnus CA Sleep and Snore Device with Patient Monitoring - 00863039000454 Catalog Number :

Device Class : 2

Duns Number: 075438768

Premarket Exempt : No

Product Code : PLC

Prescription Use : Yes

Device Count : 1

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