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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 K112163
Device Name MONICA IF24
Applicant
Monica Healthcare
Pennyfoot St.
Nottingham,  GB NG1 1GF
Applicant Contact IAN HOW
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number884.2720
Classification Product Code
OSP  
Subsequent Product Code
HGM  
Date Received07/27/2011
Decision Date 08/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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