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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 K950420
Device Name FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
Applicant
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact JAMES R LEVANI
Correspondent
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Correspondent Contact JAMES R LEVANI
Regulation Number884.2740
Classification Product Code
HGM  
Date Received01/31/1995
Decision Date 05/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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