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510(k) K022740

DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE by Datex-Ohmeda — Product Code MLD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2002
Date Received
August 19, 2002
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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Other clearances for product code MLD

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  • K002105 — SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS (December 5, 2000)
  • K992323 — DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (November 1, 1999)
  • K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (November 25, 1998)
  • K974492 — SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYS (February 26, 1998)
  • K972121 — ACUITY CENTRAL STATION (November 7, 1997)
  • K953175 — AS/3 ESTPR MODULE (February 6, 1997)
  • K960272 — EAGLE 3000/3100 PATIENT MONITOR (October 2, 1996)