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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 K082369
Device Name CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
Applicant
EDAN INSTRUMENTS, INC.
1 ODELL PLAZA
YONKERS,  NY  10701
Applicant Contact WILLIAM STERN
Correspondent
EDAN INSTRUMENTS, INC.
1 ODELL PLAZA
YONKERS,  NY  10701
Correspondent Contact WILLIAM STERN
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
HEL  
Date Received08/18/2008
Decision Date 11/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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