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

    MULTITRAK-PLUS

    K Number: K930894 · Decision Nov 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    190
    Applicant Total
    7
    Review Days
    252

    Basic Information

    Device Name
    MULTITRAK-PLUS
    K Number
    K930894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ZYMED MEDICAL INSTRUMENTATION
    Date Received
    February 22, 1993
    Decision Date
    November 1, 1993
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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