FDA 510(k)

InMode RF Multi-System

Número K: K201150 · 2020-07-22

Data da decisão2020-07-22

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

InMode RF Multi-System is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K201150. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InMode RF Multi-System?

InMode RF Multi-System is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is InMode , Ltd.. The 510(k) number is K201150.

When did InMode RF Multi-System receive FDA 510(k) clearance?

InMode RF Multi-System received FDA 510(k) clearance on 2020-07-22, under 510(k) number K201150.

Who is the listed applicant for InMode RF Multi-System?

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

What is the FDA product code for InMode RF Multi-System?

The FDA product code for InMode RF Multi-System is GEI.

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Fonte oficial

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