FDA 510(k)

Compex HD

Número K: K182017 · 2019-04-29

Data da decisão2019-04-29

Código do produtoQGO

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Compex HD is the device name listed in this FDA 510(k) record. The listed applicant is Addent, Inc.. It received FDA 510(k) clearance on 2019-04-29 under 510(k) number K182017. The device is classified under product code QGO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Compex HD?

Compex HD is a medical device that received FDA 510(k) clearance on 2019-04-29. The listed applicant is Addent, Inc.. The 510(k) number is K182017.

When did Compex HD receive FDA 510(k) clearance?

Compex HD received FDA 510(k) clearance on 2019-04-29, under 510(k) number K182017.

Who is the listed applicant for Compex HD?

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

What is the FDA product code for Compex HD?

The FDA product code for Compex HD is QGO.

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