FDA 510(k)

Forma系統，Forma輕系統

K 號：K160195 · 2016-04-15

決定日期2016-04-15

產品代碼ONF

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Forma System, Forma Light System is the device name listed in this FDA 510(k) record. The listed applicant is Formatk Systems , Ltd.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K160195. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Forma System, Forma Light System?

Forma System, Forma Light System is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Formatk Systems , Ltd.. The 510(k) number is K160195.

When did Forma System, Forma Light System receive FDA 510(k) clearance?

Forma System, Forma Light System received FDA 510(k) clearance on 2016-04-15, under 510(k) number K160195.

Who is the listed applicant for Forma System, Forma Light System?

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

What is the FDA product code for Forma System, Forma Light System?

The FDA product code for Forma System, Forma Light System is ONF.

其他以 Formatk Systems , Ltd. 為申請人之記錄

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相關器械（代碼：ONF）

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