Home / 510(k) Clearances / K132139

510(k) K132139

DELTEX MEDICAL CARDIOQ-EDM+ by Deltex Medical Limited — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2013
Date Received
July 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Deltex Medical Limited

  • K172457 — Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM (June 28, 2018)
  • K150347 — Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ (July 24, 2015)
  • K142932 — Deltex Medical KDP72 Doppler Probe (January 22, 2015)
  • K111542 — DELTEX MEDICAL CARDIOQ EDM (October 20, 2011)
  • K073593 — I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 (January 29, 2009)

Other clearances for product code DPW

  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K251114 — FloPatch FP120 (June 20, 2025)
  • K243852 — Elfor-L (April 14, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K223843 — FloPatch FP120 (May 3, 2023)
  • K222242 — FloPatch FP120 (December 9, 2022)
  • K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2) (April 20, 2022)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
  • K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
  • K201114 — Bidop 7 (January 5, 2021)