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FDA 510(k)

Cerebra Sleep System

K-Number: K213007 · 2022-07-06

Decision Date2022-07-06
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cerebra Sleep System is the device name listed in this FDA 510(k) record. The listed applicant is Cerebra Medical , Ltd.. It received FDA 510(k) clearance on 2022-07-06 under 510(k) 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. The listed applicant is Cerebra Medical , Ltd.. The 510(k) number is K213007.

When did Cerebra Sleep System receive FDA 510(k) clearance?

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

Who is the listed applicant for Cerebra Sleep System?

The FDA 510(k) record lists Cerebra Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cerebra Sleep System?

The FDA product code for Cerebra Sleep System is OLV.

Related Devices (Code: OLV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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