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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 K925681
Device Name MYOTRAC2D/CS
Applicant
Thought Technology , Ltd.
2180 Belgrave Ave.
Montreal, Quebec,  CA H4A 2L8
Applicant Contact HAL K MYERS
Correspondent
Thought Technology , Ltd.
2180 Belgrave Ave.
Montreal, Quebec,  CA H4A 2L8
Correspondent Contact HAL K MYERS
Regulation Number884.1425
Classification Product Code
HIR  
Date Received10/13/1992
Decision Date 09/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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