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

    APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300

    K Number: K873214 · Decision Jun 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    47
    Applicant Total
    254
    Review Days
    292

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    Basic Information

    Device Name
    APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
    K Number
    K873214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    General Electric Co.
    Date Received
    August 14, 1987
    Decision Date
    June 1, 1988
    Product Code
    DPT
    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
    DPT Probe, Blood-Flow, Extravascular

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