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510(k) K943256

CARDIAC OUTPUT OPTION 39 by Medical Data Electronics — Product Code DXG

K943256 is an FDA 510(k) premarket notification submitted by Medical Data Electronics for the device "CARDIAC OUTPUT OPTION 39". The FDA issued a decision of Substantially Equivalent on December 15, 1994. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Medical Data Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
July 6, 1994
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 Medical Data Electronics

  • K014294 — MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 2040 (January 25, 2002)
  • K012336 — MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 (October 3, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K992413 — ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR (August 19, 1999)
  • K992411 — ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR (August 18, 1999)
  • K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (November 25, 1998)
  • K970763 — MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR (July 14, 1997)
  • K970011 — ESCORT II CLINICAL THERMOMETRY MODULE (CTM) (July 9, 1997)
  • K970012 — ESCORT LINK CENTRAL STATION MONITOR (June 26, 1997)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)

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)

FDA data resources