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510(k) K111542

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2011
Date Received
June 2, 2011
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)
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  • K142932 — Deltex Medical KDP72 Doppler Probe (January 22, 2015)
  • K132139 — DELTEX MEDICAL CARDIOQ-EDM+ (October 10, 2013)
  • K073593 — I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 (January 29, 2009)

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