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FDA 510(k)

Cerebra Sleep System

K-Number: K213007 · 2022-07-06

ApplicantCerebra Medical , Ltd.
Decision Date2022-07-06
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cerebra Sleep System is a medical device manufactured by Cerebra Medical , Ltd.. It received FDA 510(k) clearance on 2022-07-06 under approval number K213007. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cerebra Sleep System?

Cerebra Sleep System is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Cerebra Medical , Ltd.. The 510(k) number is K213007.

When was Cerebra Sleep System approved by the FDA?

Cerebra Sleep System received FDA 510(k) clearance on 2022-07-06, under approval number K213007.

What company makes Cerebra Sleep System?

Cerebra Sleep System is manufactured by Cerebra Medical , Ltd..

What is the FDA product code for Cerebra Sleep System?

The FDA product code for Cerebra Sleep System is OLV.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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