Cerebra Sleep System— 510(k) K213007

Substantially Equivalent

Cerebra Medical , Ltd.

FDA 510(k) clearance K213007 for Cerebra Sleep System, Substantially Equivalent on 2022-07-06. Applicant: Cerebra Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Cerebra Medical , Ltd.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2021-09-20
Decision date: 2022-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winnipeg, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.