K-number	K221568
Device name	KOLO Evolution XHD Series Ultrasound Diagnostic System
Applicant	Kolo Medical (Suzhou) Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Sep 12, 2022
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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KOLO Evolution XHD Series Ultrasound Diagnostic System

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