FDA 510(k)

PowerDot PD-01MT

K号: K181759 · 2018-11-09

决定日期2018-11-09

产品代码IPF

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决定实质等同

器械摘要

PowerDot PD-01MT is the device name listed in this FDA 510(k) record. The listed applicant is Smartmissimo Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K181759. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PowerDot PD-01MT?

PowerDot PD-01MT is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Smartmissimo Technologies Pte, Ltd.. The 510(k) number is K181759.

When did PowerDot PD-01MT receive FDA 510(k) clearance?

PowerDot PD-01MT received FDA 510(k) clearance on 2018-11-09, under 510(k) number K181759.

Who is the listed applicant for PowerDot PD-01MT?

The FDA 510(k) record lists Smartmissimo Technologies Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerDot PD-01MT?

The FDA product code for PowerDot PD-01MT is IPF.

列明Smartmissimo Technologies Pte, 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。

K210938PowerDot PD-01MT2 肌肉刺激器 K210269PowerDot PD-01MT2 肌肉刺激器 K172876PowerDot PD-01M

官方来源

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