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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 K143695
Device Name CENTRAL MONITORING SYSTEM
Applicant
Edan Instruments, Inc.
3/F - B Nanshan Medical Equipments Park
Nanhai Rd. 1019#
Shenzhen,  CN 518067
Applicant Contact QUEENA CHEN
Correspondent
Edan Medical
1200 Crossman Ave.
Suite 200
Sunnyvale,  CA  94089
Correspondent Contact DOUG WORTH
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/24/2014
Decision Date 03/30/2015
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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