BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EDM

    K Number: K951369 · Decision Nov 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    3
    Review Days
    225

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    Basic Information

    Device Name
    EDM
    K Number
    K951369
    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
    Date Received
    March 27, 1995
    Decision Date
    November 7, 1995
    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

    K Number Device Name
    K052989 DP240 240 HOUR DOPPLER PROBE
    K031706 CARDIOQ, MODEL 9051-7005