FDA 510(k)

Voyant Electrosurgical Generator

N.º K: K182244 · 2018-10-11

SolicitanteApplied Medical Resources Corp.

Fecha de decisión2018-10-11

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Voyant Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K182244. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Voyant Electrosurgical Generator?

Voyant Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K182244.

When did Voyant Electrosurgical Generator receive FDA 510(k) clearance?

Voyant Electrosurgical Generator received FDA 510(k) clearance on 2018-10-11, under 510(k) number K182244.

Who is the listed applicant for Voyant Electrosurgical Generator?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant Electrosurgical Generator?

The FDA product code for Voyant Electrosurgical Generator is GEI.

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Fuente oficial

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