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FDA 510(k)

KLICK (变体:POWER, RACE, MONSTER)

K号: K222502 · 2022-12-16

决定日期2022-12-16
产品代码ITI
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

KLICK (VARIANTS: POWER, RACE, MONSTER) is the device name listed in this FDA 510(k) record. The listed applicant is Klaxon Mobility GmbH. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K222502. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KLICK (VARIANTS: POWER, RACE, MONSTER)?

KLICK (VARIANTS: POWER, RACE, MONSTER) is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Klaxon Mobility GmbH. The 510(k) number is K222502.

When did KLICK (VARIANTS: POWER, RACE, MONSTER) receive FDA 510(k) clearance?

KLICK (VARIANTS: POWER, RACE, MONSTER) received FDA 510(k) clearance on 2022-12-16, under 510(k) number K222502.

Who is the listed applicant for KLICK (VARIANTS: POWER, RACE, MONSTER)?

The FDA 510(k) record lists Klaxon Mobility GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLICK (VARIANTS: POWER, RACE, MONSTER)?

The FDA product code for KLICK (VARIANTS: POWER, RACE, MONSTER) is ITI.

相关临床试验

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列明Klaxon Mobility GmbH为申报人的其他记录

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相关器械(代码:ITI)

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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