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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 K844866
Device Name NYTONE ENURETIC ALARM BEDWETTING DEVICE
Applicant
Nytone Medical
2424 S. 900 W.
Salt Lake City,  UT  84119
Applicant Contact LLEWELLYN
Correspondent
Nytone Medical
2424 S. 900 W.
Salt Lake City,  UT  84119
Correspondent Contact LLEWELLYN
Regulation Number876.2040
Classification Product Code
KPN  
Date Received12/14/1984
Decision Date 04/03/1985
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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