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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 K850538
Device Name BED SENTRY, MODEL 50U
Applicant
Metatech Corp.
203 Westbrook Dr.
Austin,  TX  78746
Applicant Contact WIDNER
Correspondent
Metatech Corp.
203 Westbrook Dr.
Austin,  TX  78746
Correspondent Contact WIDNER
Regulation Number876.2040
Classification Product Code
KPN  
Date Received02/11/1985
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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