FDA 510(k)

Functional MR V1.0

K-Number: K221426 · 2022-07-06

Decision Date2022-07-06

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Functional MR V1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical S.A.S.. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K221426. 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 Functional MR V1.0?

Functional MR V1.0 is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Olea Medical S.A.S.. The 510(k) number is K221426.

When did Functional MR V1.0 receive FDA 510(k) clearance?

Functional MR V1.0 received FDA 510(k) clearance on 2022-07-06, under 510(k) number K221426.

Who is the listed applicant for Functional MR V1.0?

The FDA 510(k) record lists Olea Medical S.A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Functional MR V1.0?

The FDA product code for Functional MR V1.0 is LLZ.

Other records listing Olea Medical S.A.S. 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.