FDA 510(k)

ASAHI Gladius Mongo18 PV ES

K 號：K153106 · 2016-06-21

決定日期2016-06-21

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

ASAHI Fielder XT-A, ASAHI Fielder XT-R is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2016-06-21 under 510(k) number K153106. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ASAHI Fielder XT-A, ASAHI Fielder XT-R?

ASAHI Fielder XT-A, ASAHI Fielder XT-R is a medical device that received FDA 510(k) clearance on 2016-06-21. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K153106.

When did ASAHI Fielder XT-A, ASAHI Fielder XT-R receive FDA 510(k) clearance?

ASAHI Fielder XT-A, ASAHI Fielder XT-R received FDA 510(k) clearance on 2016-06-21, under 510(k) number K153106.

Who is the listed applicant for ASAHI Fielder XT-A, ASAHI Fielder XT-R?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI Fielder XT-A, ASAHI Fielder XT-R?

The FDA product code for ASAHI Fielder XT-A, ASAHI Fielder XT-R is DQX.

其他以 Asahi Intecc Co., Ltd. 為申請人之記錄

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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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