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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 K112317
Device Name FM-9000 PLUS FETAL AND MATERNAL MONITOR
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 WEST 20 ST
HIALEAH,  FL  33010
Applicant Contact JORGE MILLAN
Correspondent
ADVANCED INSTRUMENTATIONS, INC.
601 WEST 20 ST
HIALEAH,  FL  33010
Correspondent Contact JORGE MILLAN
Regulation Number884.2740
Classification Product Code
HGM  
Date Received08/11/2011
Decision Date 12/21/2011
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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