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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 K182190
Device Name Fetal Doppler
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
Rm. 202, Haogu Industry Park, 2037 Guanguang Rd.,
Guangming District
Shenzhen,  CN 518105
Applicant Contact Qihuan Zhao
Correspondent
Shenzhen AOJ Medical Technology Co., Ltd.
Rm. 202, Haogu Industry Park, 2037 Guanguang Rd.,
Guangming District
Shenzhen,  CN 518105
Correspondent Contact Qihuan Zhao
Regulation Number884.2660
Classification Product Code
KNG  
Date Received08/13/2018
Decision Date 12/19/2018
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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