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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 K190120
Device Name VINNO 8, VINNO 6, VINNO 5
Applicant
Vinno Technology (Suzhou) Co.,Ltd
5f Bldg. A, 4f Bldg. C # 27 Xinfa Rd.
Suzhou Industrial Park
Suzhou,  CN 215123
Applicant Contact Wei Wang
Correspondent
Vinno Technology (Suzhou) Co.,Ltd
5f Bldg. A, 4f Bldg. C # 27 Xinfa Rd.
Suzhou Industrial Park
Suzhou,  CN 215123
Correspondent Contact Sherry Zhang
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/24/2019
Decision Date 01/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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