FDA 510(k)

FOX 810, FOX 980

N.º K: K220531 · 2022-09-01

Fecha de decisión2022-09-01

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

FOX 810, FOX 980 is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C Laser GmbH. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K220531. 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 FOX 810, FOX 980?

FOX 810, FOX 980 is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is A.R.C Laser GmbH. The 510(k) number is K220531.

When did FOX 810, FOX 980 receive FDA 510(k) clearance?

FOX 810, FOX 980 received FDA 510(k) clearance on 2022-09-01, under 510(k) number K220531.

Who is the listed applicant for FOX 810, FOX 980?

The FDA 510(k) record lists A.R.C Laser GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOX 810, FOX 980?

The FDA product code for FOX 810, FOX 980 is GEX. This falls under the Gastroenterology category.

Otros registros que enlistan a A.R.C Laser GmbH como solicitante

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K192272Wolf445nm K170183Cetus system, Cetus probe K161403Fibras y Probes de Fibra Óptica Quirúrgica A.R.C.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.