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

    TRACE MODEL# 840, 841,842 & 845 ARM BOARD

    K Number: K925502 · Decision Jan 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    74

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    Basic Information

    Device Name
    TRACE MODEL# 840, 841,842 & 845 ARM BOARD
    K Number
    K925502
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5210
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trace Medical Equipment, Inc.
    Date Received
    October 30, 1992
    Decision Date
    January 12, 1993
    Product Code
    KMK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KMK Device, Intravascular Catheter Securement

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    Other Clearances by Trace Medical Equipment, Inc.

    K Number Device Name
    K925145 TRACE MODEL #'S 840, 841, 842, 845