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FDA 510(k)

Persona C HR

K-Number: K250282 · 2025-04-30

ApplicantA.T.S. Applicazione Tecnologie Speciali S.R.L.
Decision Date2025-04-30
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Persona C HR is the device name listed in this FDA 510(k) record. The listed applicant is A.T.S. Applicazione Tecnologie Speciali S.R.L.. It received FDA 510(k) clearance on 2025-04-30 under 510(k) number K250282. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Persona C HR?

Persona C HR is a medical device that received FDA 510(k) clearance on 2025-04-30. The listed applicant is A.T.S. Applicazione Tecnologie Speciali S.R.L.. The 510(k) number is K250282.

When did Persona C HR receive FDA 510(k) clearance?

Persona C HR received FDA 510(k) clearance on 2025-04-30, under 510(k) number K250282.

Who is the listed applicant for Persona C HR?

The FDA 510(k) record lists A.T.S. Applicazione Tecnologie Speciali S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Persona C HR?

The FDA product code for Persona C HR is OWB.

Other records listing A.T.S. Applicazione Tecnologie Speciali S.R.L. 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.

K211777ARCO FP-SK211542PRIMO SK182086ARCO FP

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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.

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