FDA 510(k)

Persona C HR

K号: K250282 · 2025-04-30

申请人A.T.S. Applicazione Tecnologie Speciali S.R.L.

决定日期2025-04-30

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明A.T.S. Applicazione Tecnologie Speciali S.R.L.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K211777ARCO FP-S K211542PRIMO S K182086ARCO FP

官方来源

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