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FDA 510(k)

OEC Elite

K号: K172550 · 2017-11-16

决定日期2017-11-16
产品代码OXO
咨询委员会RA
决定实质等同

器械摘要

OEC Elite is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K172550. 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?

OEC Elite is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Ge Oec Medical Systems, Inc.. The 510(k) number is K172550.

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

OEC Elite received FDA 510(k) clearance on 2017-11-16, under 510(k) number K172550.

Who is the listed applicant for OEC Elite?

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

What is the FDA product code for OEC Elite?

The FDA product code for OEC Elite is OXO.

相关临床试验

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列明Ge Oec Medical Systems, Inc.为申报人的其他记录

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相关器械(代码:OXO)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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