FDA 510(k)

MindsEye Expandable Port

Número K: K202072 · 2020-08-26

Data da decisão2020-08-26

Código do produtoGZT

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MindsEye Expandable Port is the device name listed in this FDA 510(k) record. The listed applicant is Minnetronix Neuro, Inc.. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K202072. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MindsEye Expandable Port?

MindsEye Expandable Port is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Minnetronix Neuro, Inc.. The 510(k) number is K202072.

When did MindsEye Expandable Port receive FDA 510(k) clearance?

MindsEye Expandable Port received FDA 510(k) clearance on 2020-08-26, under 510(k) number K202072.

Who is the listed applicant for MindsEye Expandable Port?

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

What is the FDA product code for MindsEye Expandable Port?

The FDA product code for MindsEye Expandable Port is GZT.

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