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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 K212084
Device Name Fetal Doppler
Applicant
Shenzhen Mericonn Technology Co., Ltd.
Rm. 20203, Bldg. 6, Donglongxing Kejiyuan, Huaning Rd.
Xinshishequ, Dalang St.
Shenzhen,  CN 518109
Applicant Contact Jiang Chuanyuan
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 508, Block C, # 1029 Nanhai Ave., Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number884.2660
Classification Product Code
KNG  
Date Received07/02/2021
Decision Date 11/03/2021
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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