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FDA 510(k)

Cerebrotech CMS-5000

K-Number: K171186 · 2017-12-08

Decision Date2017-12-08
Product CodeQAF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cerebrotech CMS-5000 is a medical device manufactured by Cerebrotech Medical Systems. It received FDA 510(k) clearance on 2017-12-08 under approval number K171186. The device is classified under product code QAF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cerebrotech CMS-5000?

Cerebrotech CMS-5000 is a medical device that received FDA 510(k) clearance on 2017-12-08. It is manufactured by Cerebrotech Medical Systems. The 510(k) number is K171186.

When was Cerebrotech CMS-5000 approved by the FDA?

Cerebrotech CMS-5000 received FDA 510(k) clearance on 2017-12-08, under approval number K171186.

What company makes Cerebrotech CMS-5000?

Cerebrotech CMS-5000 is manufactured by Cerebrotech Medical Systems.

What is the FDA product code for Cerebrotech CMS-5000?

The FDA product code for Cerebrotech CMS-5000 is QAF.

Related Devices (Code: QAF)

Official Source

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