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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K993411
Device Name FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
Applicant
Mega Electronics , Ltd.
200 N. Main St.
South Bldg., Suite 6
East Longmeadow,  MA  01028
Applicant Contact DAVID MAHONEY
Correspondent
Mega Electronics , Ltd.
200 N. Main St.
South Bldg., Suite 6
East Longmeadow,  MA  01028
Correspondent Contact DAVID MAHONEY
Regulation Number884.1425
Classification Product Code
HIR  
Subsequent Product Code
KPI  
Date Received10/12/1999
Decision Date 01/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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