FDA 510(k)

Icobrain

K-Number: K192130 · 2019-12-13

Decision Date2019-12-13

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Icobrain is the device name listed in this FDA 510(k) record. The listed applicant is Icometrix NV. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192130. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Icobrain?

Icobrain is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Icometrix NV. The 510(k) number is K192130.

When did Icobrain receive FDA 510(k) clearance?

Icobrain received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192130.

Who is the listed applicant for Icobrain?

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

What is the FDA product code for Icobrain?

The FDA product code for Icobrain is LLZ.

Other records listing Icometrix NV 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.

K240712icobrain aria K192962icobrain-ctp K181939icobrain

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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.