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510(k) K142932

Deltex Medical KDP72 Doppler Probe by Deltex Medical Limited — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2015
Date Received
October 9, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

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  • 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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