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

    FETH-R-KATH

    K Number: K981329 · Decision Aug 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    74
    Applicant Total
    12
    Review Days
    135

    Basic Information

    Device Name
    FETH-R-KATH
    K Number
    K981329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    EPIMED INTERNATIONAL, INC.
    Date Received
    April 13, 1998
    Decision Date
    August 26, 1998
    Product Code
    BSO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSO Catheter, Conduction, Anesthetic

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