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510(k) K971840

OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM by Invivo Research, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1998
Date Received
May 19, 1997
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

Other clearances by Invivo Research, Inc.

  • K050399 — MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 (August 26, 2005)
  • K043354 — MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 (January 10, 2005)
  • K041918 — INTEGRATED PATIENT MONITORING SYSTEM (October 15, 2004)
  • K040915 — MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M (September 22, 2004)
  • K002604 — CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM (February 7, 2002)
  • K002030 — OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES (September 26, 2000)
  • K980045 — CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM (November 16, 1998)
  • K974581 — MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT (October 28, 1998)
  • K955045 — OMNI-TRAK PATIENT MONITORING SYSTEM (July 11, 1996)
  • K945138 — OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS (November 20, 1995)

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