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 the device name listed in this FDA 510(k) record. The listed applicant is Cerebrotech Medical Systems. It received FDA 510(k) clearance on 2017-12-08 under 510(k) 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. The listed applicant is Cerebrotech Medical Systems. The 510(k) number is K171186.

When did Cerebrotech CMS-5000 receive FDA 510(k) clearance?

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

Who is the listed applicant for Cerebrotech CMS-5000?

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

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

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

Other records listing Cerebrotech Medical Systems as applicant

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.

K182967Visor System

Related Devices (Code: QAF)

K253840STEDI Scan DeviceStroke DX K182967Visor SystemCerebrotech Medical Systems, Inc.

Official Source

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