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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 K200780
Device Name XBit Series Digital Color Doppler Ultrasound System
Applicant
CHISON Medical Technologies Co., Ltd.
No.228, Changjiang East Road, Block 51 and 53,
Phase 5, Shuofang Industrial Park
Wuxi,  CN 214142
Applicant Contact Qifei Liu
Correspondent
CHISON Medical Technologies Co., Ltd.
No.228, Changjiang East Road, Block 51 and 53,
Phase 5, Shuofang Industrial Park
Wuxi,  CN 214142
Correspondent Contact Qifei Liu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/25/2020
Decision Date 08/05/2020
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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