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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 K141194
Device Name FM-3000 FETAL MONITOR
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 WEST 20 STREET
HIALEAH,  FL  33010
Applicant Contact JORGE MILLAN
Correspondent
ADVANCED INSTRUMENTATIONS, INC.
601 WEST 20 STREET
HIALEAH,  FL  33010
Correspondent Contact JORGE MILLAN
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Codes
HFN   HGP   HGS  
Date Received05/08/2014
Decision Date 11/19/2014
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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