FDA 510(k)

Visor System

K-Number: K182967 · 2018-11-23

ApplicantCerebrotech Medical Systems, Inc.

Decision Date2018-11-23

Product CodeQAF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Visor System is the device name listed in this FDA 510(k) record. The listed applicant is Cerebrotech Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-11-23 under 510(k) number K182967. 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 Visor System?

Visor System is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Cerebrotech Medical Systems, Inc.. The 510(k) number is K182967.

When did Visor System receive FDA 510(k) clearance?

Visor System received FDA 510(k) clearance on 2018-11-23, under 510(k) number K182967.

Who is the listed applicant for Visor System?

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

What is the FDA product code for Visor System?

The FDA product code for Visor System is QAF.

Other records listing Cerebrotech Medical Systems, Inc. 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.

K171186Cerebrotech CMS-5000

Related Devices (Code: QAF)

K253840STEDI Scan DeviceStroke DX K171186Cerebrotech CMS-5000Cerebrotech Medical Systems

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.