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FDA 510(k)

BC-5

N.º K: K191693 · 2019-11-01

SolicitanteReveallux, Corp
Fecha de decisión2019-11-01
Código de productoGEX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

BC-5 is the device name listed in this FDA 510(k) record. The listed applicant is Reveallux, Corp. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K191693. 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.

Preguntas frecuentes

What is the BC-5?

BC-5 is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Reveallux, Corp. The 510(k) number is K191693.

When did BC-5 receive FDA 510(k) clearance?

BC-5 received FDA 510(k) clearance on 2019-11-01, under 510(k) number K191693.

Who is the listed applicant for BC-5?

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

What is the FDA product code for BC-5?

The FDA product code for BC-5 is GEX. This falls under the Gastroenterology category.

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Fuente oficial

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