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FDA 510(k)

icobrain-ctp

K-Number: K192962 · 2020-02-28

ApplicantIcometrix NV
Decision Date2020-02-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

icobrain-ctp is a medical device manufactured by Icometrix NV. It received FDA 510(k) clearance on 2020-02-28 under approval number K192962. 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-ctp?

icobrain-ctp is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Icometrix NV. The 510(k) number is K192962.

When was icobrain-ctp approved by the FDA?

icobrain-ctp received FDA 510(k) clearance on 2020-02-28, under approval number K192962.

What company makes icobrain-ctp?

icobrain-ctp is manufactured by Icometrix NV.

What is the FDA product code for icobrain-ctp?

The FDA product code for icobrain-ctp is LLZ.

Other Devices by Icometrix NV

Related Devices (Code: LLZ)

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.