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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 K942057
Device Name FISHER-PRICE DRY NIGHT MONITOR
Applicant
Fisher Price
636 Girard Ave.
East Aurora,  NY  14052
Applicant Contact GARY JONES
Correspondent
Fisher Price
636 Girard Ave.
East Aurora,  NY  14052
Correspondent Contact GARY JONES
Regulation Number876.2040
Classification Product Code
KPN  
Date Received04/28/1994
Decision Date 07/28/1994
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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