FDA 510(k)

icobrain-ctp

K-Number: K192962 · 2020-02-28

Decision Date2020-02-28

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

icobrain-ctp is the device name listed in this FDA 510(k) record. The listed applicant is Icometrix NV. It received FDA 510(k) clearance on 2020-02-28 under 510(k) 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. The listed applicant is Icometrix NV. The 510(k) number is K192962.

When did icobrain-ctp receive FDA 510(k) clearance?

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

Who is the listed applicant for icobrain-ctp?

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-ctp?

The FDA product code for icobrain-ctp 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 K192130Icobrain 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.