Home / 510(k) Clearances / K834408

510(k) K834408

TX-2 THERMAL DILUTION CARDIAC OUTPUT by Waters Instruments, Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1984
Date Received
December 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Waters Instruments, Inc.

  • K053169 — RM3 RENAL PRESERVATION SYSTEM (January 17, 2006)
  • K042224 — RM3 RENAL PRESERVATION SYSTEM (October 22, 2004)
  • K971571 — RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT (July 29, 1997)
  • K921519 — OXICOM-2100 (October 23, 1992)
  • K911207 — OXICOMPLUS (August 26, 1991)
  • K863210 — VELCOM-100 (November 26, 1986)
  • K862161 — OSC-80 OXIMETER (August 18, 1986)
  • K852909 — MVP - 6000 (November 14, 1985)
  • K841876 — POLYURETHANE THERMAL DILUTION CATHET (July 13, 1984)
  • K813585 — WATERS ILEOSTOMY VALVE (April 9, 1982)

Other clearances for product code DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K212529 — Hypotension Decision Assist Model HDA-OR2 (November 23, 2021)
  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K193179 — EV1000 Clinical Platform (December 17, 2019)
  • K190955 — Hypotension Decision Assist (November 27, 2019)
  • K181372 — Argos (December 13, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)