FDA 510(k)

Slow Wave DS8

N.º K: K191320 · 2020-10-02

Fecha de decisión2020-10-02

Código de productoLQZ

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Slow Wave DS8 is the device name listed in this FDA 510(k) record. The listed applicant is Slow Wave, Inc.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K191320. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Slow Wave DS8?

Slow Wave DS8 is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Slow Wave, Inc.. The 510(k) number is K191320.

When did Slow Wave DS8 receive FDA 510(k) clearance?

Slow Wave DS8 received FDA 510(k) clearance on 2020-10-02, under 510(k) number K191320.

Who is the listed applicant for Slow Wave DS8?

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

What is the FDA product code for Slow Wave DS8?

The FDA product code for Slow Wave DS8 is LQZ.

Otros registros que enlistan a Slow Wave, Inc. 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.

K240463Slow Wave DS8 (SWDS802)

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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.