FDA 510(k)

Electronic Pulse Stimulator

Número K: K153520 · 2016-05-05

Data da decisão2016-05-05

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electronic Pulse Stimulator 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 2016-05-05 under 510(k) number K153520. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Electronic Pulse Stimulator?

Electronic Pulse Stimulator is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K153520.

When did Electronic Pulse Stimulator receive FDA 510(k) clearance?

Electronic Pulse Stimulator received FDA 510(k) clearance on 2016-05-05, under 510(k) number K153520.

Who is the listed applicant for Electronic Pulse Stimulator?

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?

The FDA product code for Electronic Pulse Stimulator is NUH.

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Fonte oficial

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