FDA 510(k)

KOLO Evolution XHD Series Ultrasound Diagnostic System

Numéro K : K221568 · 2022-09-12

DemandeurKolo Medical (Suzhou) Co., Ltd.

Date de décision2022-09-12

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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