FDA 510(k)

Maxpower Relief

Número K: K182120 · 2019-01-10

Data da decisão2019-01-10

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Maxpower Relief is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K182120. 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 Maxpower Relief?

Maxpower Relief is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K182120.

When did Maxpower Relief receive FDA 510(k) clearance?

Maxpower Relief received FDA 510(k) clearance on 2019-01-10, under 510(k) number K182120.

Who is the listed applicant for Maxpower Relief?

The FDA 510(k) record lists Omron Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Maxpower Relief?

The FDA product code for Maxpower Relief is NUH.

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Fonte oficial

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