FDA 510(k)

Action Trackstander型號TR1816, TR1820, TR2016, 和TR2020

K 號：K163451 · 2018-01-12

決定日期2018-01-12

產品代碼IPL

諮詢委員會PM

決定相當於

器材摘要

Action Trackstander models TR1816, TR1820, TR2016, and TR2020 is the device name listed in this FDA 510(k) record. The listed applicant is Action Manufacturing, Inc.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K163451. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Action Trackstander models TR1816, TR1820, TR2016, and TR2020?

Action Trackstander models TR1816, TR1820, TR2016, and TR2020 is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Action Manufacturing, Inc.. The 510(k) number is K163451.

When did Action Trackstander models TR1816, TR1820, TR2016, and TR2020 receive FDA 510(k) clearance?

Action Trackstander models TR1816, TR1820, TR2016, and TR2020 received FDA 510(k) clearance on 2018-01-12, under 510(k) number K163451.

Who is the listed applicant for Action Trackstander models TR1816, TR1820, TR2016, and TR2020?

The FDA 510(k) record lists Action Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Action Trackstander models TR1816, TR1820, TR2016, and TR2020?

The FDA product code for Action Trackstander models TR1816, TR1820, TR2016, and TR2020 is IPL.

其他以 Action Manufacturing, Inc. 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。

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相關器械（代碼：IPL）

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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