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510(k) K936051

OMNI-CENTRAL STATION MONITOR by Invivo Research, Inc. — Product Code DRT

K936051 is an FDA 510(k) premarket notification submitted by Invivo Research, Inc. for the device "OMNI-CENTRAL STATION MONITOR". The FDA issued a decision of Substantially Equivalent on July 6, 1994. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Invivo Research, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1994
Date Received
December 20, 1993
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.

  • 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 DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • 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)

FDA data resources