Home / 510(k) Clearances / K790047

510(k) K790047

CARDIAC OUTPUT COMPUTER, MDEL 9520A by Edwards Laboratories — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1979
Date Received
January 5, 1979
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 Edwards Laboratories

  • K801552 — MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR (July 28, 1980)
  • K800655 — MODEL 100 SPECTRAVIEW (April 16, 1980)
  • K792441 — CARPENTIER-EDWARDS FLEX. ANNULOPLASTY (March 17, 1980)
  • K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER (December 7, 1979)
  • K790022 — DISPOSABLE HOLDER FOR BIOPROSTHESIS (January 15, 1979)
  • K781535 — AC ADAPTER:MODELS 9525,9526,9527 (September 15, 1978)
  • K771663 — PROBE & CATHETER (September 20, 1977)
  • K771046 — VENA CAVA UMBRELLA FILTER, MODEL 7321 (June 22, 1977)
  • K760151 — APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) (August 26, 1976)
  • K760192 — COMPUTER, THERMODILUTION CARDIAC (9520) (July 19, 1976)

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)