FDA 510(k)

icobrain aria

K-Number: K240712 · 2024-11-07

Decision Date2024-11-07

Product CodeQBS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

icobrain aria is the device name listed in this FDA 510(k) record. The listed applicant is Icometrix NV. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K240712. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the icobrain aria?

icobrain aria is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Icometrix NV. The 510(k) number is K240712.

When did icobrain aria receive FDA 510(k) clearance?

icobrain aria received FDA 510(k) clearance on 2024-11-07, under 510(k) number K240712.

Who is the listed applicant for icobrain aria?

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 aria?

The FDA product code for icobrain aria is QBS.

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.

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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.