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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 K182710
Device Name Fetal Doppler, Model FD88
Applicant
ShenzZhen Luckcome Technology Inc., Ltd.
Floor 6A, 6th Building , Tongfuyu Industrial Park,
Nanshan District
Shenzhen,  CN 518055
Applicant Contact Can He
Correspondent
ShenzZhen Luckcome Technology Inc., Ltd.
Floor 6A, 6th Building , Tongfuyu Industrial Park,
Nanshan District
Shenzhen,  CN 518055
Correspondent Contact Linli He
Regulation Number884.2660
Classification Product Code
KNG  
Date Received09/27/2018
Decision Date 03/01/2019
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
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