510(k) K934369

DRI SLEEPER by Laborie Medical Technologies, Ltd. — Product Code KPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1993
Date Received
September 7, 1993
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