KOLO Evolution XHD Series Ultrasound Diagnostic System
K-Number: K221568 · 2022-09-12
Device Summary
Frequently Asked Questions
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.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: IYN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.