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

    NEO-PNEUMOCATH

    K Number: K955474 · Decision Feb 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    76
    Applicant Total
    1
    Review Days
    75

    Basic Information

    Device Name
    NEO-PNEUMOCATH
    K Number
    K955474
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    INTRA SPECIAL CATHETERS GMBH
    Date Received
    November 30, 1995
    Decision Date
    February 13, 1996
    Product Code
    GBX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBX Catheter, Irrigation

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