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FDA 510(k)

Quingo Flyte 电动轮椅

K号: K171256 · 2017-06-08

决定日期2017-06-08
产品代码INI
咨询委员会PM 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Quingo Flyte Mobility Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Agile Distributors, LLC. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K171256. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quingo Flyte Mobility Scooter?

Quingo Flyte Mobility Scooter is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Agile Distributors, LLC. The 510(k) number is K171256.

When did Quingo Flyte Mobility Scooter receive FDA 510(k) clearance?

Quingo Flyte Mobility Scooter received FDA 510(k) clearance on 2017-06-08, under 510(k) number K171256.

Who is the listed applicant for Quingo Flyte Mobility Scooter?

The FDA 510(k) record lists Agile Distributors, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quingo Flyte Mobility Scooter?

The FDA product code for Quingo Flyte Mobility Scooter is INI.

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相关器械(代码:INI)

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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