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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 K852518
Device Name MODIFICATION FETAL MONITOR MODEL FM-2
Applicant
ADVANTAGE MEDICAL SYSTEMS, INC.
925 SHERMAN AVE.
HAMDEN,  CT  06514
Applicant Contact ANTHONY CALDERONI
Correspondent
ADVANTAGE MEDICAL SYSTEMS, INC.
925 SHERMAN AVE.
HAMDEN,  CT  06514
Correspondent Contact ANTHONY CALDERONI
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/12/1985
Decision Date 07/05/1985
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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