FDA 510(k)

Velocity Alpha Highspeed Surgical Drill System

N.º K: K191479 · 2021-04-11

Fecha de decisión2021-04-11

Código de productoHBE

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Velocity Alpha Highspeed Surgical Drill System is the device name listed in this FDA 510(k) record. The listed applicant is Adeor Medical AG. It received FDA 510(k) clearance on 2021-04-11 under 510(k) number K191479. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Velocity Alpha Highspeed Surgical Drill System?

Velocity Alpha Highspeed Surgical Drill System is a medical device that received FDA 510(k) clearance on 2021-04-11. The listed applicant is Adeor Medical AG. The 510(k) number is K191479.

When did Velocity Alpha Highspeed Surgical Drill System receive FDA 510(k) clearance?

Velocity Alpha Highspeed Surgical Drill System received FDA 510(k) clearance on 2021-04-11, under 510(k) number K191479.

Who is the listed applicant for Velocity Alpha Highspeed Surgical Drill System?

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

What is the FDA product code for Velocity Alpha Highspeed Surgical Drill System?

The FDA product code for Velocity Alpha Highspeed Surgical Drill System is HBE.

Ensayos clínicos relacionados

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Otros registros que enlistan a Adeor Medical AG como solicitante

K253772Velocity Alpha MR High Speed Surgical Drill System K191847Adeor Medical nxt No adherente Bipolar Forceps, Adeor Medical nxt No adherente Bipolar Forceps de Uso Único

Dispositivos relacionados (Código: HBE)

Fuente oficial

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