FDA 510(k)

Solax 电动滑板车（型号：S204311M, S204161, S204143）

K号: K190737 · 2021-05-10

申请人Dongguan Prestige Sporting Goods Co., Ltd.

决定日期2021-05-10

产品代码INI

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决定实质等同

器械摘要

Solax Electric Scooter (Models: S204311M, S204161, S204143) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Prestige Sporting Goods Co., Ltd.. It received FDA 510(k) clearance on 2021-05-10 under 510(k) number K190737. 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 Solax Electric Scooter (Models: S204311M, S204161, S204143)?

Solax Electric Scooter (Models: S204311M, S204161, S204143) is a medical device that received FDA 510(k) clearance on 2021-05-10. The listed applicant is Dongguan Prestige Sporting Goods Co., Ltd.. The 510(k) number is K190737.

When did Solax Electric Scooter (Models: S204311M, S204161, S204143) receive FDA 510(k) clearance?

Solax Electric Scooter (Models: S204311M, S204161, S204143) received FDA 510(k) clearance on 2021-05-10, under 510(k) number K190737.

Who is the listed applicant for Solax Electric Scooter (Models: S204311M, S204161, S204143)?

The FDA 510(k) record lists Dongguan Prestige Sporting Goods Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solax Electric Scooter (Models: S204311M, S204161, S204143)?

The FDA product code for Solax Electric Scooter (Models: S204311M, S204161, S204143) is INI.

列明Dongguan Prestige Sporting Goods Co., Ltd.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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