FDA 510(k)

SCAR 3

Número K: K211362 · 2021-08-25

RequerenteEl.En Electronic Engineering Spa

Data da decisão2021-08-25

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SCAR 3 is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K211362. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SCAR 3?

SCAR 3 is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K211362.

When did SCAR 3 receive FDA 510(k) clearance?

SCAR 3 received FDA 510(k) clearance on 2021-08-25, under 510(k) number K211362.

Who is the listed applicant for SCAR 3?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCAR 3?

The FDA product code for SCAR 3 is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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