FDA 510(k)

Maxima Electric System

Número K: K180845 · 2019-07-25

RequerenteHandpiece Headquarters - Hpr, Inc.

Data da decisão2019-07-25

Código do produtoEBW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Maxima Electric System is the device name listed in this FDA 510(k) record. The listed applicant is Handpiece Headquarters - Hpr, Inc.. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K180845. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Maxima Electric System?

Maxima Electric System is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Handpiece Headquarters - Hpr, Inc.. The 510(k) number is K180845.

When did Maxima Electric System receive FDA 510(k) clearance?

Maxima Electric System received FDA 510(k) clearance on 2019-07-25, under 510(k) number K180845.

Who is the listed applicant for Maxima Electric System?

The FDA 510(k) record lists Handpiece Headquarters - Hpr, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Maxima Electric System?

The FDA product code for Maxima Electric System is EBW.

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