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FDA 510(k)

ART-Plan (v.2.2.0)

K-Number: K234068 · 2024-04-22

Decision Date2024-04-22
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ART-Plan (v.2.2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Therapanacea Sas. It received FDA 510(k) clearance on 2024-04-22 under 510(k) number K234068. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ART-Plan (v.2.2.0)?

ART-Plan (v.2.2.0) is a medical device that received FDA 510(k) clearance on 2024-04-22. The listed applicant is Therapanacea Sas. The 510(k) number is K234068.

When did ART-Plan (v.2.2.0) receive FDA 510(k) clearance?

ART-Plan (v.2.2.0) received FDA 510(k) clearance on 2024-04-22, under 510(k) number K234068.

Who is the listed applicant for ART-Plan (v.2.2.0)?

The FDA 510(k) record lists Therapanacea Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ART-Plan (v.2.2.0)?

The FDA product code for ART-Plan (v.2.2.0) is MUJ.

Other records listing Therapanacea Sas 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.

Related Devices (Code: MUJ)

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.

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.