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510(k) K122121

PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE by Pulsion Medical Systems SE — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2012
Date Received
July 17, 2012
Clearance Type
Special
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 Pulsion Medical Systems SE

  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K171620 — PiCCO Catheter (February 21, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)

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)