FDA 510(k)

OEC エリートミニビューウェイ

K番号: K160131 · 2016-06-21

決定日2016-06-21

製品コードOXO

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてGe Hangwei Medical Systems Co., Ltd.を記載するその他の記録

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