Compumedics Usa, Inc.

Compumedics Usa, Inc.

Address:5015 West WT Harris Blvd, Suite E,Charlotte,NC,28269,US

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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

Full-Montage Standard Electroencephalograph (GWQ) (2) Standard Polysomnograph With Electroencephalograph (OLV) (2)

Premarket Exempt

No

Clear

Siesta - 09342451001788 Catalog Number : 9007-0060-00

Device Description : Siesta 802 Basic PSG System w/o Software

Device Class : 2

Duns Number: 111312307

Premarket Exempt : No

Product Code : OLV, GWQ

Prescription Use : Yes

Device Count : 1

Siesta - 09342451002112 Catalog Number : 9007-0061-01

Device Description : Siesta 802 Basic EEG System w/o Software

Device Class : 2

Duns Number: 111312307

Premarket Exempt : No

Product Code : OLV, GWQ

Prescription Use : Yes

Device Count : 1

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