FDA 510(k)

Soniquence RF Generator and Soniquence Electrodes

Número K: K183611 · 2019-05-22

Data da decisão2019-05-22

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Soniquence RF Generator and Soniquence Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Soniquence, LLC. It received FDA 510(k) clearance on 2019-05-22 under 510(k) number K183611. 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 Soniquence RF Generator and Soniquence Electrodes?

Soniquence RF Generator and Soniquence Electrodes is a medical device that received FDA 510(k) clearance on 2019-05-22. The listed applicant is Soniquence, LLC. The 510(k) number is K183611.

When did Soniquence RF Generator and Soniquence Electrodes receive FDA 510(k) clearance?

Soniquence RF Generator and Soniquence Electrodes received FDA 510(k) clearance on 2019-05-22, under 510(k) number K183611.

Who is the listed applicant for Soniquence RF Generator and Soniquence Electrodes?

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

What is the FDA product code for Soniquence RF Generator and Soniquence Electrodes?

The FDA product code for Soniquence RF Generator and Soniquence Electrodes is GEI.

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Fonte oficial

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