FDA 510(k)

ARC 400

N.º K: K193591 · 2020-04-02

SolicitanteBowa-Electronics GmbH & Co. KG

Fecha de decisión2020-04-02

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ARC 400 is the device name listed in this FDA 510(k) record. The listed applicant is Bowa-Electronics GmbH & Co. KG. It received FDA 510(k) clearance on 2020-04-02 under 510(k) number K193591. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ARC 400?

ARC 400 is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Bowa-Electronics GmbH & Co. KG. The 510(k) number is K193591.

When did ARC 400 receive FDA 510(k) clearance?

ARC 400 received FDA 510(k) clearance on 2020-04-02, under 510(k) number K193591.

Who is the listed applicant for ARC 400?

The FDA 510(k) record lists Bowa-Electronics GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARC 400?

The FDA product code for ARC 400 is GEI.

Otros registros que enlistan a Bowa-Electronics GmbH & Co. KG como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K173877BOWA Neutral Electrodes

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Fuente oficial

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