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

    BATTERY OPERATED FLOW RATE COMPUTER

    K Number: K760756 · Decision Oct 15, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    76
    Review Days
    14

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    Basic Information

    Device Name
    BATTERY OPERATED FLOW RATE COMPUTER
    K Number
    K760756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    3M Health Care, Sarns
    Date Received
    October 1, 1976
    Decision Date
    October 15, 1976
    Product Code
    DXG
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function

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