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FDA 510(k)

羅盤針與MAP

K 號:K161408 · 2016-11-22

決定日期2016-11-22
產品代碼DRS
諮詢委員會履歷
決定相當於

器材摘要

Compass Cast and MAP is the device name listed in this FDA 510(k) record. The listed applicant is Centurion Medical Products Corporation. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161408. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Compass Cast and MAP?

Compass Cast and MAP is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Centurion Medical Products Corporation. The 510(k) number is K161408.

When did Compass Cast and MAP receive FDA 510(k) clearance?

Compass Cast and MAP received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161408.

Who is the listed applicant for Compass Cast and MAP?

The FDA 510(k) record lists Centurion Medical Products Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Compass Cast and MAP?

The FDA product code for Compass Cast and MAP is DRS.

相關臨床試驗

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相關器械(代碼:DRS)

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。

官方來源

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