FDA 510(k)

Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

Número K: K192542 · 2020-06-16

RequerenteModern Medical Equipment Manufacturing, Ltd.

Data da decisão2020-06-16

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. It received FDA 510(k) clearance on 2020-06-16 under 510(k) number K192542. 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 Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde?

Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde is a medical device that received FDA 510(k) clearance on 2020-06-16. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. The 510(k) number is K192542.

When did Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde receive FDA 510(k) clearance?

Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde received FDA 510(k) clearance on 2020-06-16, under 510(k) number K192542.

Who is the listed applicant for Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde?

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

What is the FDA product code for Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde?

The FDA product code for Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde is GEI.

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Fonte oficial

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