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510(k) K103142

SPACELABS MULTI-PARAMETER MODULE by Spacelabs Healthcare, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2011
Date Received
October 25, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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