FDA 510(k)

C.T.M. 行動輪椅 HS-268

K 號：K192885 · 2019-12-09

決定日期2019-12-09

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

C.T.M. Mobility Scooter HS-268 is the device name listed in this FDA 510(k) record. The listed applicant is Chien TI Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K192885. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the C.T.M. Mobility Scooter HS-268?

C.T.M. Mobility Scooter HS-268 is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Chien TI Enterprise Co., Ltd.. The 510(k) number is K192885.

When did C.T.M. Mobility Scooter HS-268 receive FDA 510(k) clearance?

C.T.M. Mobility Scooter HS-268 received FDA 510(k) clearance on 2019-12-09, under 510(k) number K192885.

Who is the listed applicant for C.T.M. Mobility Scooter HS-268?

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

What is the FDA product code for C.T.M. Mobility Scooter HS-268?

The FDA product code for C.T.M. Mobility Scooter HS-268 is INI.

其他以 Chien TI Enterprise Co., Ltd. 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。

K181344C.T.M 行動輪椅 K162952C.T.M. 行動輪椅

相關器械（代碼：INI）

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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官方來源

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