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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 K800303
Device Name ELECTRONIC PERINEOMETER
Applicant
Associates IN Biofeedback
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Associates IN Biofeedback
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.1425
Classification Product Code
HIR  
Date Received02/11/1980
Decision Date 03/03/1980
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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