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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 Rd. S., Hi-Tech Industrial Park
Shenzhen,  CN 518057
Applicant Contact Jiang Xiaoyong
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg.,Keji 12th Rd. S.,
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
Predetermined Change
Control Plan Authorized		 No
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