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FDA 510(k)

Aquilo Sports CCT1500 System

N.º K: K223164 · 2022-11-04

SolicitanteAquilo Sports, LLC
Fecha de decisión2022-11-04
Código de productoIRP
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Aquilo Sports CCT1500 System is the device name listed in this FDA 510(k) record. The listed applicant is Aquilo Sports, LLC. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K223164. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Aquilo Sports CCT1500 System?

Aquilo Sports CCT1500 System is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Aquilo Sports, LLC. The 510(k) number is K223164.

When did Aquilo Sports CCT1500 System receive FDA 510(k) clearance?

Aquilo Sports CCT1500 System received FDA 510(k) clearance on 2022-11-04, under 510(k) number K223164.

Who is the listed applicant for Aquilo Sports CCT1500 System?

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

What is the FDA product code for Aquilo Sports CCT1500 System?

The FDA product code for Aquilo Sports CCT1500 System is IRP.

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