FDA 510(k)

Medtronic Model 5392 External Pulse Generator (EPG)

Número K: K201011 · 2020-05-13

Data da decisão2020-05-13

Código do produtoDTE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medtronic Model 5392 External Pulse Generator (EPG) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K201011. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medtronic Model 5392 External Pulse Generator (EPG)?

Medtronic Model 5392 External Pulse Generator (EPG) is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Medtronic, Inc.. The 510(k) number is K201011.

When did Medtronic Model 5392 External Pulse Generator (EPG) receive FDA 510(k) clearance?

Medtronic Model 5392 External Pulse Generator (EPG) received FDA 510(k) clearance on 2020-05-13, under 510(k) number K201011.

Who is the listed applicant for Medtronic Model 5392 External Pulse Generator (EPG)?

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

What is the FDA product code for Medtronic Model 5392 External Pulse Generator (EPG)?

The FDA product code for Medtronic Model 5392 External Pulse Generator (EPG) is DTE.

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Fonte oficial

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