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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 K140579
Device Name ULTRASONIC POCKET DOPPLER
Applicant
Edan Instruments, Inc.
Nanhai Rd. 1019 # Shekou, Nanshan
Shenzhen, Guangdong,  CN 518067
Applicant Contact QUEENA CHEN
Correspondent
Edan Instruments, Inc.
Nanhai Rd. 1019 # Shekou, Nanshan
Shenzhen, Guangdong,  CN 518067
Correspondent Contact QUEENA CHEN
Regulation Number884.2660
Classification Product Code
KNG  
Subsequent Product Code
DPW  
Date Received03/06/2014
Decision Date 02/06/2015
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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