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FDA 510(k)

Instrument tray, for semi-rigid ureteroscope

K号: K203492 · 2021-09-15

决定日期2021-09-15
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 tray, for semi-rigid ureteroscope 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 2021-09-15 under 510(k) number K203492. 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 tray, for semi-rigid ureteroscope?

Instrument tray, for semi-rigid ureteroscope is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K203492.

When did Instrument tray, for semi-rigid ureteroscope receive FDA 510(k) clearance?

Instrument tray, for semi-rigid ureteroscope received FDA 510(k) clearance on 2021-09-15, under 510(k) number K203492.

Who is the listed applicant for Instrument tray, for semi-rigid ureteroscope?

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 tray, for semi-rigid ureteroscope?

The FDA product code for Instrument tray, for semi-rigid ureteroscope is KCT.

相关临床试验

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列明Olympus Winter & Ibe GmbH为申报人的其他记录

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相关器械(代码:KCT)

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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