FDA 510(k)

Instrument basket, for EndoEYE

K号: K171692 · 2018-04-02

决定日期2018-04-02

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Instrument basket, for EndoEYE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2018-04-02 under 510(k) number K171692. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Instrument basket, for EndoEYE?

Instrument basket, for EndoEYE is a medical device that received FDA 510(k) clearance on 2018-04-02. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K171692.

When did Instrument basket, for EndoEYE receive FDA 510(k) clearance?

Instrument basket, for EndoEYE received FDA 510(k) clearance on 2018-04-02, under 510(k) number K171692.

Who is the listed applicant for Instrument basket, for EndoEYE?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Instrument basket, for EndoEYE?

The FDA product code for Instrument basket, for EndoEYE is KCT.

列明Olympus Winter & Ibe GmbH为申报人的其他记录

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。

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