FDA 510(k)

EyeCTester

Número K: K203594 · 2022-09-07

RequerenteNeuro-Eye Diagnostic Systems, LLC

Data da decisão2022-09-07

Código do produtoQTW

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

EyeCTester is the device name listed in this FDA 510(k) record. The listed applicant is Neuro-Eye Diagnostic Systems, LLC. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K203594. The device is classified under product code QTW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EyeCTester?

EyeCTester is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Neuro-Eye Diagnostic Systems, LLC. The 510(k) number is K203594.

When did EyeCTester receive FDA 510(k) clearance?

EyeCTester received FDA 510(k) clearance on 2022-09-07, under 510(k) number K203594.

Who is the listed applicant for EyeCTester?

The FDA 510(k) record lists Neuro-Eye Diagnostic Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EyeCTester?

The FDA product code for EyeCTester is QTW.

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