BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM

    K Number: K172457 · Decision Jun 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    6
    Review Days
    318

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    Basic Information

    Device Name
    Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
    K Number
    K172457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deltex Medical Limited
    Date Received
    August 14, 2017
    Decision Date
    June 28, 2018
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Deltex Medical Limited

    K Number Device Name
    K150347 Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
    K142932 Deltex Medical KDP72 Doppler Probe
    K132139 DELTEX MEDICAL CARDIOQ-EDM+
    K111542 DELTEX MEDICAL CARDIOQ EDM
    K073593 I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016