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510(k) K935020

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

K935020 is an FDA 510(k) premarket notification submitted by Invivo Research, Inc. for the device "OMNI-TRAC MODIFICATION". The FDA issued a decision of Substantially Equivalent on April 26, 1995. The device falls under product code MLD (Monitor, St Segment With Alarm), a Class II device regulated under 21 CFR 870.1025. Invivo Research, Inc. has at least 10 other 510(k) clearances on record.

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

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)
  • K971840 — OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM (March 4, 1998)
  • K955045 — OMNI-TRAK PATIENT MONITORING SYSTEM (July 11, 1996)

Other clearances for product code MLD

  • K101602 — VITAL SIGNS MONITOR (September 1, 2010)
  • K080461 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 (March 13, 2008)
  • K022740 — DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAR (November 14, 2002)
  • 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)

FDA data resources