FDA 510(k)

OEC Elite MiniView

K 號：K160131 · 2016-06-21

決定日期2016-06-21

產品代碼OXO

諮詢委員會RA

決定相當於

器材摘要

OEC Elite MiniView is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2016-06-21 under 510(k) number K160131. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OEC Elite MiniView?

OEC Elite MiniView is a medical device that received FDA 510(k) clearance on 2016-06-21. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K160131.

When did OEC Elite MiniView receive FDA 510(k) clearance?

OEC Elite MiniView received FDA 510(k) clearance on 2016-06-21, under 510(k) number K160131.

Who is the listed applicant for OEC Elite MiniView?

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

What is the FDA product code for OEC Elite MiniView?

The FDA product code for OEC Elite MiniView is OXO.

其他以 Ge Hangwei Medical Systems Co., Ltd. 為申請人之記錄

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相關器械（代碼：OXO）

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