FDA 510(k)

TRACOE vario

N.º K: K203362 · 2021-08-05

Fecha de decisión2021-08-05

Código de productoJOH

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

TRACOE vario is the device name listed in this FDA 510(k) record. The listed applicant is Tracoe Medical GmbH. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K203362. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TRACOE vario?

TRACOE vario is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Tracoe Medical GmbH. The 510(k) number is K203362.

When did TRACOE vario receive FDA 510(k) clearance?

TRACOE vario received FDA 510(k) clearance on 2021-08-05, under 510(k) number K203362.

Who is the listed applicant for TRACOE vario?

The FDA 510(k) record lists Tracoe Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACOE vario?

The FDA product code for TRACOE vario is JOH.

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Otros registros que enlistan a Tracoe Medical GmbH como solicitante

K172720TRACOE silcosoft Tracheostomy Tube K152778TRACOE Cuff Pressure Monitor K152865TRACOE smart Cuff Manager

Dispositivos relacionados (Código: JOH)

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Fuente oficial

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