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FDA 510(k)

Icobrain

K-Number: K192130 · 2019-12-13

ApplicantIcometrix NV
Decision Date2019-12-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Icobrain is a medical device manufactured by Icometrix NV. It received FDA 510(k) clearance on 2019-12-13 under approval 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. It is manufactured by Icometrix NV. The 510(k) number is K192130.

When was Icobrain approved by the FDA?

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

What company makes Icobrain?

Icobrain is manufactured by Icometrix NV.

What is the FDA product code for Icobrain?

The FDA product code for Icobrain is LLZ.

Other Devices by Icometrix NV

K181939icobrain K192962icobrain-ctp K240712icobrain aria

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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.

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