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510(k) K935020

OMNI-TRAC MODIFICATION by Invivo Research, Inc. — Product Code MLD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1995
Date Received
October 20, 1993
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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  • K980045 — CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM (November 16, 1998)
  • K974581 — MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT (October 28, 1998)
  • K971840 — OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM (March 4, 1998)
  • K955045 — OMNI-TRAK PATIENT MONITORING SYSTEM (July 11, 1996)

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  • K012837 — MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES (September 14, 2001)
  • 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)