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510(k) K122146

XHIBIT CENTRAL STATION, MODEL 96102 by Spacelabs Healthcare — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2013
Date Received
July 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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