FDA 510(k)

DigiGuide System

Número K: K193499 · 2020-11-04

Data da decisão2020-11-04

Código do produtoDZJ

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DigiGuide System is the device name listed in this FDA 510(k) record. The listed applicant is Protomed, Inc.. It received FDA 510(k) clearance on 2020-11-04 under 510(k) number K193499. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DigiGuide System?

DigiGuide System is a medical device that received FDA 510(k) clearance on 2020-11-04. The listed applicant is Protomed, Inc.. The 510(k) number is K193499.

When did DigiGuide System receive FDA 510(k) clearance?

DigiGuide System received FDA 510(k) clearance on 2020-11-04, under 510(k) number K193499.

Who is the listed applicant for DigiGuide System?

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

What is the FDA product code for DigiGuide System?

The FDA product code for DigiGuide System is DZJ.

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