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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 K100797
Device Name FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
Applicant
EDAN INSTRUMENTS, INC.
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
EDAN INSTRUMENTS, INC.
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number884.2740
Classification Product Code
HGM  
Date Received03/22/2010
Decision Date 11/10/2010
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
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