FDA 510(k)

Glaucoma Module

Número K: K200954 · 2020-08-03

RequerenteTopcon Healthcare Solutions, Inc.

Data da decisão2020-08-03

Código do produtoNFJ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Glaucoma Module is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2020-08-03 under 510(k) number K200954. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Glaucoma Module?

Glaucoma Module is a medical device that received FDA 510(k) clearance on 2020-08-03. The listed applicant is Topcon Healthcare Solutions, Inc.. The 510(k) number is K200954.

When did Glaucoma Module receive FDA 510(k) clearance?

Glaucoma Module received FDA 510(k) clearance on 2020-08-03, under 510(k) number K200954.

Who is the listed applicant for Glaucoma Module?

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

What is the FDA product code for Glaucoma Module?

The FDA product code for Glaucoma Module is NFJ.

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