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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 K011304
Device Name OB-1 FETAL MONITOR
Applicant
ANALOGIC CORP.
360 AUDUBON RD.
WAKEFIELD,  MA  01880
Applicant Contact STEVEN A CLARKE
Correspondent
ANALOGIC CORP.
360 AUDUBON RD.
WAKEFIELD,  MA  01880
Correspondent Contact STEVEN A CLARKE
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/30/2001
Decision Date 05/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
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