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

    PACH-PEN CALCULATOR

    K Number: K884619 · Decision Feb 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    PACH-PEN CALCULATOR
    K Number
    K884619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Oculab, Inc.
    Date Received
    November 4, 1988
    Decision Date
    February 2, 1989
    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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    K860061 OCULAB BIOMETRICPEN
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