510(k) K871659

IMS-2000S STRESS MONITOR by Integrated Medical Systems, Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1987
Date Received
April 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type