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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 K073221
Device Name CADENCE II
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  
Date Received11/15/2007
Decision Date 12/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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