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

    OMNI-TRAC MODIFICATION

    K Number: K935020 · Decision Apr 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    13
    Applicant Total
    14
    Review Days
    553

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    Basic Information

    Device Name
    OMNI-TRAC MODIFICATION
    K Number
    K935020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Invivo Research, Inc.
    Date Received
    October 20, 1993
    Decision Date
    April 26, 1995
    Product Code
    MLD
    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
    MLD Monitor, St Segment With Alarm

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