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

    CPX, CCM, CATH WITH 15% CO2

    K Number: K955432 · Decision Jul 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    23
    Review Days
    216

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    Basic Information

    Device Name
    CPX, CCM, CATH WITH 15% CO2
    K Number
    K955432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Graphics Corp.
    Date Received
    November 28, 1995
    Decision Date
    July 1, 1996
    Product Code
    BZM
    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
    BZM Calculator, Pulmonary Function Interpretor (Diagnostic)

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