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510(k) K861437

QMED SYSTEM 2150 by Qmed, Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1986
Date Received
April 17, 1986
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 Qmed, Inc.

  • K972991 — MONITOR ONE NDX (December 3, 1998)
  • K932109 — PROFILOMAT (December 3, 1993)
  • K921476 — INTERP-1000 (October 21, 1992)
  • K897121 — QEKG ELECTROCARDIOGRAPH (April 30, 1990)
  • K873591 — A.R.M. (ASPEN RETURN MONITOR) (September 30, 1987)
  • K862377 — QMED SELF ADHERING ELECTRODE (September 26, 1986)
  • K863091 — BICORD BY QMED (August 29, 1986)
  • K843559 — KLEENIT BY QMED (October 24, 1984)
  • K841172 — MONITOR ONE (July 27, 1984)
  • K840465 — Q-MED ELECTRODE (June 19, 1984)

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)