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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, heart sound, fetal, ultrasonic
510(k) Number K142769
Device Name Fetal Doppler
Applicant
iCare Newlife Technologies, Inc.
Wangjing Science Pioneer Park, Suite E-510A, Chaoyang
Beijing,  CN 100102
Applicant Contact BO XIAO
Correspondent
Guangzhou Osmunda Medical Device Consulting Co., Ltd
7th floor, Jingui Business Building, No. 982 Congyun Rd.,
Baiyun District,  CN 510420
Correspondent Contact MIKE GU
Regulation Number884.2660
Classification Product Code
HEK  
Date Received09/25/2014
Decision Date 03/20/2015
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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