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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 K162172
Device Name EBit Series Diagnostic Ultrasound System
Applicant
Chison Medical Imaging Co., Ltd.
#228, Changjiang E. Rd.,Block 51 And 53,
Phase 5 Industrial Park Shoufa
Wuxi,  CN 214142
Applicant Contact QIFEI LIU
Correspondent
Leiker Regulatory & Quality Consulting
4157 N. Del Rey Ave.
Clovis,  CA  93619
Correspondent Contact BOB LEIKER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/03/2016
Decision Date 09/14/2016
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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