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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 Bldg., # 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
Predetermined Change
Control Plan Authorized		 No
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