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

    INTERSPEC APOGEE

    K Number: K903839 · Decision Nov 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    17
    Review Days
    87

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    Basic Information

    Device Name
    INTERSPEC APOGEE
    K Number
    K903839
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Interspec, Inc.
    Date Received
    August 21, 1990
    Decision Date
    November 16, 1990
    Product Code
    DXK
    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
    DXK Echocardiograph

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    K920678 ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER
    K911073 PROBE REFILL KIT
    K910049 INTERSPEC APOGEE, MODIFICATION
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