FDA 510(k)

KOLO Evolution XHD Series Ultrasound Diagnostic System

N.º K: K221568 · 2022-09-12

SolicitanteKolo Medical (Suzhou) Co., Ltd.

Fecha de decisión2022-09-12

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

KOLO Evolution XHD Series Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Kolo Medical (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-09-12 under 510(k) number K221568. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the KOLO Evolution XHD Series Ultrasound Diagnostic System?

KOLO Evolution XHD Series Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2022-09-12. The listed applicant is Kolo Medical (Suzhou) Co., Ltd.. The 510(k) number is K221568.

When did KOLO Evolution XHD Series Ultrasound Diagnostic System receive FDA 510(k) clearance?

KOLO Evolution XHD Series Ultrasound Diagnostic System received FDA 510(k) clearance on 2022-09-12, under 510(k) number K221568.

Who is the listed applicant for KOLO Evolution XHD Series Ultrasound Diagnostic System?

The FDA 510(k) record lists Kolo Medical (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOLO Evolution XHD Series Ultrasound Diagnostic System?

The FDA product code for KOLO Evolution XHD Series Ultrasound Diagnostic System is IYN.

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