FDA 510(k)

ABC D-FLEX PROBE

K 號：K151229 · 2016-06-02

決定日期2016-06-02

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

ABC D-FLEX PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K151229. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ABC D-FLEX PROBE?

ABC D-FLEX PROBE is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Conmed Corporation. The 510(k) number is K151229.

When did ABC D-FLEX PROBE receive FDA 510(k) clearance?

ABC D-FLEX PROBE received FDA 510(k) clearance on 2016-06-02, under 510(k) number K151229.

Who is the listed applicant for ABC D-FLEX PROBE?

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

What is the FDA product code for ABC D-FLEX PROBE?

The FDA product code for ABC D-FLEX PROBE is GEI.

其他以 Conmed Corporation 為申請人之記錄

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相關器械（代碼：GEI）

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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