FDA 510(k)

ARCO FP-S

K 號：K211777 · 2021-08-13

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

決定日期2021-08-13

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

ARCO FP-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 2021-08-13 under 510(k) number K211777. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARCO FP-S?

ARCO FP-S is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is A.T.S. Applicazione Tecnologie Speciali S.R.L.. The 510(k) number is K211777.

When did ARCO FP-S receive FDA 510(k) clearance?

ARCO FP-S received FDA 510(k) clearance on 2021-08-13, under 510(k) number K211777.

Who is the listed applicant for ARCO FP-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 ARCO FP-S?

The FDA product code for ARCO FP-S is OWB.

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

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。

K250282Persona C HR K211542PRIMO S K182086ARCO FP

相關器械（代碼：OWB）

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。

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH Corporation K254205Zenition 30Philips Medical Systems Nederland B.V.K260607防護系統（西門子 30x40）Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。