FDA 510(k)

Red Dot

N.º K: K191556 · 2020-02-28

SolicitanteBehold.Ai Technologies Limited

Fecha de decisión2020-02-28

Código de productoQFM

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Red Dot is the device name listed in this FDA 510(k) record. The listed applicant is Behold.Ai Technologies Limited. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K191556. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Red Dot?

Red Dot is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Behold.Ai Technologies Limited. The 510(k) number is K191556.

When did Red Dot receive FDA 510(k) clearance?

Red Dot received FDA 510(k) clearance on 2020-02-28, under 510(k) number K191556.

Who is the listed applicant for Red Dot?

The FDA 510(k) record lists Behold.Ai Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Red Dot?

The FDA product code for Red Dot is QFM.

Dispositivos relacionados (Código: QFM)

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Fuente oficial

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