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510(k) K080461

STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 by Philips Medical Systems — Product Code MLD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2008
Date Received
February 20, 2008
Clearance Type
Special
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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  • K974492 — SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYS (February 26, 1998)
  • K972121 — ACUITY CENTRAL STATION (November 7, 1997)
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  • K960272 — EAGLE 3000/3100 PATIENT MONITOR (October 2, 1996)