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FDA 510(k)

OEC Elite MiniView

K号: K171800 · 2017-07-12

决定日期2017-07-12
产品代码OXO
咨询委员会RA
决定实质等同

器械摘要

OEC Elite MiniView is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K171800. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OEC Elite MiniView?

OEC Elite MiniView is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K171800.

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

OEC Elite MiniView received FDA 510(k) clearance on 2017-07-12, under 510(k) number K171800.

Who is the listed applicant for OEC Elite MiniView?

The FDA 510(k) record lists Ge Hualun 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.

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列明Ge Hualun Medical Systems Co. , Ltd.为申报人的其他记录

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相关器械(代码:OXO)

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官方来源

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