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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 Echo, Ultrasonic
510(k) Number K170856
Device Name CMS600P2 B-Ultrasound Diagnostic System
Applicant
Contec Medical Systems Co.,Ltd
#112 Qinhuang W. St.
Economic & Technical Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Xueyong Li
Correspondent
Beijing Believe Technology Service Co., Ltd.
5-1206, Build 332, Dafangju, #25 Banbidian Rd.
Liyuan Town, Tongzhou District,  CN 101121
Correspondent Contact Ray Wang
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/22/2017
Decision Date 11/17/2017
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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