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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 K200643
Device Name Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., LTD
Keji 12th Road South, Hi-tech Industrial Park
Shenzhen,  CN 518057
Applicant Contact Jiang Xiaoyong
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., LTD
Mindray Building,Keji 12th Road South,
Hi-tech Industrial Park
Nanshan, Shenzhen,  CN 518057
Correspondent Contact Jiang Xiaoyong
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/11/2020
Decision Date 07/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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