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510(k) K152935

LiDCOunity Monitor by Lidco, Ltd. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2016
Date Received
October 5, 2015
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 Lidco, Ltd.

  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)
  • K131048 — LIDCO CNAP MODULE (August 28, 2013)
  • K122247 — LIDCORAPID V2 MONITOR (March 20, 2013)
  • K023960 — LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 (January 9, 2003)
  • K010049 — PULSECO HEMODYNAMIC MONITOR CM71 (June 14, 2001)
  • K962918 — LIDCO SYSTEM (January 8, 1999)

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  • 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)