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Standard Polysomnograph With Electroencephalograph

FDA product code OLV · 64 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1400
Review panel
NE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1986-04-17 – 2026-08-25

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

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