FDA 510(k)

电子脉冲刺激器型号：PL-029K12和PL-029K13

K号: K162517 · 2017-04-14

决定日期2017-04-14

产品代码NUH

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决定实质等同

器械摘要

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 is the device name listed in this FDA 510(k) record. The listed applicant is Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K162517. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K162517.

When did Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 receive FDA 510(k) clearance?

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 received FDA 510(k) clearance on 2017-04-14, under 510(k) number K162517.

Who is the listed applicant for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

The FDA 510(k) record lists Jkh Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

The FDA product code for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 is NUH.

列明Jkh Health 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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