BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    UNILECT, MONITAB AND BIOTRACE-HR

    K Number: K944497 · Decision May 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    7
    Review Days
    612

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    Basic Information

    Device Name
    UNILECT, MONITAB AND BIOTRACE-HR
    K Number
    K944497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Msb , Ltd.
    Date Received
    September 13, 1994
    Decision Date
    May 17, 1996
    Product Code
    DRX
    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
    DRX Electrode, Electrocardiograph

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