510(k) K974492

SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS by Siemens Medical Solutions USA, Inc. — Product Code MLD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1998
Date Received
November 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, St Segment With Alarm
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type