FDA 510(k)

DEX Device

Número K: K191878 · 2021-01-29

Data da decisão2021-01-29

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DEX Device is the device name listed in this FDA 510(k) record. The listed applicant is Dex Surgical. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K191878. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DEX Device?

DEX Device is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Dex Surgical. The 510(k) number is K191878.

When did DEX Device receive FDA 510(k) clearance?

DEX Device received FDA 510(k) clearance on 2021-01-29, under 510(k) number K191878.

Who is the listed applicant for DEX Device?

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

What is the FDA product code for DEX Device?

The FDA product code for DEX Device is GEI.

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