FDA 510(k)

Progreat

K 號：K170223 · 2017-07-21

申請人Ashitaka Factory of Terumo Corporation

決定日期2017-07-21

產品代碼DQO

諮詢委員會履歷

決定相當於

器材摘要

Progreat is the device name listed in this FDA 510(k) record. The listed applicant is Ashitaka Factory of Terumo Corporation. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K170223. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Progreat?

Progreat is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Ashitaka Factory of Terumo Corporation. The 510(k) number is K170223.

When did Progreat receive FDA 510(k) clearance?

Progreat received FDA 510(k) clearance on 2017-07-21, under 510(k) number K170223.

Who is the listed applicant for Progreat?

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

What is the FDA product code for Progreat?

The FDA product code for Progreat is DQO.

其他以 Ashitaka Factory of Terumo Corporation 為申請人之記錄

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相關器械（代碼：DQO）

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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