510(k) K213007

Cerebra Sleep System by Cerebra Medical , Ltd. — Product Code OLV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 6, 2022
Date Received: September 20, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Standard Polysomnograph With Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

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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