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510(k) K172457

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM by Deltex Medical Limited — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2018
Date Received
August 14, 2017
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

  • K150347 — Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ (July 24, 2015)
  • K142932 — Deltex Medical KDP72 Doppler Probe (January 22, 2015)
  • K132139 — DELTEX MEDICAL CARDIOQ-EDM+ (October 10, 2013)
  • 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)

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