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

    PORTABLE ACUIOMETER

    K Number: K842567 · Decision Aug 15, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    46
    Applicant Total
    6
    Review Days
    44

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    Basic Information

    Device Name
    PORTABLE ACUIOMETER
    K Number
    K842567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Randwal Instrument Co., Inc.
    Date Received
    July 2, 1984
    Decision Date
    August 15, 1984
    Product Code
    HLJ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HLJ Ophthalmoscope, Battery-Powered

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