FDA 510(k)

泰坦3W

K 號：K160835 · 2017-02-02

決定日期2017-02-02

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

Titan 3W is the device name listed in this FDA 510(k) record. The listed applicant is Tzora Active Systems , Ltd.. It received FDA 510(k) clearance on 2017-02-02 under 510(k) number K160835. 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 Titan 3W?

Titan 3W is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is Tzora Active Systems , Ltd.. The 510(k) number is K160835.

When did Titan 3W receive FDA 510(k) clearance?

Titan 3W received FDA 510(k) clearance on 2017-02-02, under 510(k) number K160835.

Who is the listed applicant for Titan 3W?

The FDA 510(k) record lists Tzora Active Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Titan 3W?

The FDA product code for Titan 3W is INI.

其他以 Tzora Active Systems , Ltd. 為申請人之記錄

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K172409輕量型

相關器械（代碼：INI）

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官方來源

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