FDA 510(k)

FREDDO

Numéro K : K242132 · 2024-10-18

DemandeurFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda

Date de décision2024-10-18

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

FREDDO is the device name listed in this FDA 510(k) record. The listed applicant is Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K242132. 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 FREDDO?

FREDDO is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda. The 510(k) number is K242132.

When did FREDDO receive FDA 510(k) clearance?

FREDDO received FDA 510(k) clearance on 2024-10-18, under 510(k) number K242132.

Who is the listed applicant for FREDDO?

The FDA 510(k) record lists Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREDDO?

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

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Source officielle

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