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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 K854193
Device Name ELECTRO-MYOGRAPHIC PERINEOMETER
Applicant
Verimed Holdings, Inc.
2888 NE 25th. Ct.
Fort Lauderdale,  FL  33305
Applicant Contact WILLIAM HASSEL
Correspondent
Verimed Holdings, Inc.
2888 NE 25th. Ct.
Fort Lauderdale,  FL  33305
Correspondent Contact WILLIAM HASSEL
Regulation Number884.1425
Classification Product Code
HIR  
Date Received10/15/1985
Decision Date 06/09/1986
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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