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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K102140
Device Name FETAL MONITORS, MODELS F2 AND F3
Applicant
Edan Instruments, Inc.
Nanhai Rd. 1019#, Shekou,
Nanshen
Shenzhen, Guangdong,  CN
Applicant Contact WILLIAM STERN
Correspondent
Edan Instruments, Inc.
Nanhai Rd. 1019#, Shekou,
Nanshen
Shenzhen, Guangdong,  CN
Correspondent Contact WILLIAM STERN
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
HGL  
Date Received07/29/2010
Decision Date 01/13/2011
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
Recalls CDRH Recalls
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