FDA 510(k)

Merilas 532短脉冲，Merilas 577短脉冲，Merilas 810短脉冲

K号: K231011 · 2023-09-12

决定日期2023-09-12

产品代码HQF

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决定实质等同

器械摘要

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse is the device name listed in this FDA 510(k) record. The listed applicant is Meridian AG. It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K231011. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse?

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse is a medical device that received FDA 510(k) clearance on 2023-09-12. The listed applicant is Meridian AG. The 510(k) number is K231011.

When did Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse receive FDA 510(k) clearance?

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse received FDA 510(k) clearance on 2023-09-12, under 510(k) number K231011.

Who is the listed applicant for Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse?

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

What is the FDA product code for Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse?

The FDA product code for Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse is HQF.

列明Meridian AG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。

K232417MR Q；MR Q 仰卧；MR Q SLT K160677MICRORUPTOR 6

官方来源

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