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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alarm, Conditioned Response Enuresis
510(k) Number K782093
Device Name DETECTOR PAD
Applicant
Halperin Institute, Ltd. The
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Halperin Institute, Ltd. The
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.2040
Classification Product Code
KPN  
Date Received12/14/1978
Decision Date 02/21/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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