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510(k) K043354

MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 by Invivo Research, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2005
Date Received
December 6, 2004
Clearance Type
Special
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.

  • K050399 — MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 (August 26, 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)
  • K945138 — OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS (November 20, 1995)

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  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)
  • K202464 — Vital Sign Monitoring Sensor (Model :XK300) (April 26, 2021)