Home / 510(k) Clearances / K781805

510(k) K781805

CARDIAC COMPUTERS, CO-10 & CO-10R by Waters Assoc., Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1979
Date Received
October 24, 1978
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 Assoc., Inc.

  • K811975 — MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL (July 27, 1981)
  • K802481 — 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH (October 31, 1980)
  • K801852 — MRM-2 OXYGEN CONSUMPTION MONITOR (August 20, 1980)
  • K801431 — PAN-AM MYELOGRAM TRAY (August 12, 1980)
  • K791661 — SYSTEM CONTROLLER 720 SERIES (September 24, 1979)
  • K791026 — 4F STERILE BALLOON-LESS, CATHETER 913-28 (June 22, 1979)
  • K782175 — CARTRIDGE HOLDER, RCM 100 (February 15, 1979)
  • K790145 — SOLVENT DELIVERY SYSTEM (February 15, 1979)
  • K781915 — DATA MODULE (January 10, 1979)
  • K781692 — CALIBRATOR, DYNAMIC (November 29, 1978)

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)