BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL 100 SPECTRAVIEW

    K Number: K800655 · Decision Apr 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    12
    Review Days
    22

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    Basic Information

    Device Name
    MODEL 100 SPECTRAVIEW
    K Number
    K800655
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Edwards Laboratories
    Date Received
    March 25, 1980
    Decision Date
    April 16, 1980
    Product Code
    DQC
    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
    DQC Phonocardiograph

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