FDA 510(k)

PRIMO S

K 號：K211542 · 2021-07-09

申請人A.T.S. Applicazione Tecnologie Speciali S.R.L.

決定日期2021-07-09

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

PRIMO S 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 2021-07-09 under 510(k) number K211542. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PRIMO S?

PRIMO S is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is A.T.S. Applicazione Tecnologie Speciali S.R.L.. The 510(k) number is K211542.

When did PRIMO S receive FDA 510(k) clearance?

PRIMO S received FDA 510(k) clearance on 2021-07-09, under 510(k) number K211542.

Who is the listed applicant for PRIMO S?

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 PRIMO S?

The FDA product code for PRIMO S is MQB.

其他以 A.T.S. Applicazione Tecnologie Speciali S.R.L. 為申請人之記錄

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K250282Persona C HR K211777ARCO FP-S K182086ARCO FP

相關器械（代碼：MQB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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