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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K223920
Device Name VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P
Applicant
VINNO Technology (Suzhou) Co.,Ltd
5F Building A,4F Building C No. 27 Xinfa Rd.
Suzhou Industrial Park
Suzhou,  CN 215123
Applicant Contact Cordelia Liu
Correspondent
VINNO Technology (Suzhou) Co.,Ltd
5F Building A,4F Building C No. 27 Xinfa Rd.
Suzhou Industrial Park
Suzhou,  CN 215123
Correspondent Contact Cordelia Liu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/29/2022
Decision Date 06/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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