510(k) K850538

BED SENTRY, MODEL 50U by Metatech Corp. — Product Code KPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1985
Date Received
February 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Conditioned Response Enuresis
Device Class
Class II
Regulation Number
876.2040
Review Panel
GU
Submission Type