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510(k) K002105

SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS by Siemens Medical Solutions USA, Inc. — Product Code MLD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2000
Date Received
July 12, 2000
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

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