FDA 510(k)

SCAR 3

Numéro K : K211362 · 2021-08-25

DemandeurEl.En Electronic Engineering Spa

Date de décision2021-08-25

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Autres dossiers indiquant El.En Electronic Engineering Spa en tant que demandeur

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Source officielle

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