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

    MAXI-SCOPE OR ULTRA-SCOPE

    K Number: K912128 · Decision Jun 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    MAXI-SCOPE OR ULTRA-SCOPE
    K Number
    K912128
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Seiichi Mfg., Inc.
    Date Received
    May 14, 1991
    Decision Date
    June 28, 1991
    Product Code
    LDE
    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
    LDE Stethoscope, Manual

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