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510(k) K974581

MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT by Invivo Research, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1998
Date Received
December 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Invivo Research, Inc.

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  • 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)
  • K971840 — OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM (March 4, 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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