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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name uterine electromyographic monitor
510(k) Number K112390
Device Name MONICA AN24
Applicant
MONICA HEALTHCARE LTD.
BIOCITY, PENNYFOOT STREET
NOTTINGHAM,  GB NG1 1GF
Applicant Contact IAN HOW
Correspondent
MONICA HEALTHCARE LTD.
BIOCITY, PENNYFOOT STREET
NOTTINGHAM,  GB NG1 1GF
Correspondent Contact IAN HOW
Regulation Number884.2720
Classification Product Code
OSP  
Date Received08/18/2011
Decision Date 07/13/2012
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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