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

    3-DAY RELEASE OF ETHYLENE OXIDE DEVICE

    K Number: K832352 · Decision Jan 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    47
    Review Days
    182

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    Basic Information

    Device Name
    3-DAY RELEASE OF ETHYLENE OXIDE DEVICE
    K Number
    K832352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Parke-Davis Co.
    Date Received
    July 15, 1983
    Decision Date
    January 13, 1984
    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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