FDA 510(k)

Micromed BRAIN QUICK system

K-Number: K171384 · 2018-02-01

Decision Date2018-02-01

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Micromed BRAIN QUICK system is the device name listed in this FDA 510(k) record. The listed applicant is Micromed S.P.A.. It received FDA 510(k) clearance on 2018-02-01 under 510(k) number K171384. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Micromed BRAIN QUICK system?

Micromed BRAIN QUICK system is a medical device that received FDA 510(k) clearance on 2018-02-01. The listed applicant is Micromed S.P.A.. The 510(k) number is K171384.

When did Micromed BRAIN QUICK system receive FDA 510(k) clearance?

Micromed BRAIN QUICK system received FDA 510(k) clearance on 2018-02-01, under 510(k) number K171384.

Who is the listed applicant for Micromed BRAIN QUICK system?

The FDA 510(k) record lists Micromed S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micromed BRAIN QUICK system?

The FDA product code for Micromed BRAIN QUICK system is GWQ.

Other records listing Micromed S.P.A. 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.

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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.