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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 K002503
Device Name FETALGARD LITE
Applicant
ANALOGIC CORP.
8 CENTENNIAL DR.
PEABODY,  MA  01960
Applicant Contact STEVEN A CLARKE
Correspondent
ANALOGIC CORP.
8 CENTENNIAL DR.
PEABODY,  MA  01960
Correspondent Contact STEVEN A CLARKE
Regulation Number884.2740
Classification Product Code
HGM  
Date Received08/14/2000
Decision Date 11/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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