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FDA 510(k)

welloStationX

N.º K: K180298 · 2018-11-30

SolicitanteWello, Inc.
Fecha de decisión2018-11-30
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

welloStationX is the device name listed in this FDA 510(k) record. The listed applicant is Wello, Inc.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K180298. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the welloStationX?

welloStationX is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Wello, Inc.. The 510(k) number is K180298.

When did welloStationX receive FDA 510(k) clearance?

welloStationX received FDA 510(k) clearance on 2018-11-30, under 510(k) number K180298.

Who is the listed applicant for welloStationX?

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

What is the FDA product code for welloStationX?

The FDA product code for welloStationX is FLL.

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Dispositivos relacionados (Código: FLL)

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.

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Fuente oficial

Ver en la base de datos de la FDA →

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

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