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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K220245
Device Name Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
Applicant
Contec Medical Systems Co.,Ltd
#112 Qinhuang W. St.,
Economic & Technical Development Zone
Qinhuangdao,  CN
Applicant Contact Jie Xiao
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number884.2660
Classification Product Code
KNG  
Date Received01/28/2022
Decision Date 09/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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