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

    EXERSYSTEM(TM) MMC 5000

    K Number: K864911 · Decision Aug 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    249

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    Basic Information

    Device Name
    EXERSYSTEM(TM) MMC 5000
    K Number
    K864911
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Med Science
    Date Received
    December 15, 1986
    Decision Date
    August 21, 1987
    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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