FDA 510(k)

ISEN-Goggles with Data Viewer

Número K: K163270 · 2017-09-25

RequerenteIsent Tech & Trading Company, Ltd.

Data da decisão2017-09-25

Código do produtoGWN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ISEN-Goggles with Data Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Isent Tech & Trading Company, Ltd.. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K163270. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ISEN-Goggles with Data Viewer?

ISEN-Goggles with Data Viewer is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Isent Tech & Trading Company, Ltd.. The 510(k) number is K163270.

When did ISEN-Goggles with Data Viewer receive FDA 510(k) clearance?

ISEN-Goggles with Data Viewer received FDA 510(k) clearance on 2017-09-25, under 510(k) number K163270.

Who is the listed applicant for ISEN-Goggles with Data Viewer?

The FDA 510(k) record lists Isent Tech & Trading Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISEN-Goggles with Data Viewer?

The FDA product code for ISEN-Goggles with Data Viewer is GWN.

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