BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DISTOMETER

    K Number: K882575 · Decision Jul 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    9

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    Basic Information

    Device Name
    DISTOMETER
    K Number
    K882575
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1190
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Hagg-Streit Service, Inc.
    Date Received
    June 22, 1988
    Decision Date
    July 1, 1988
    Product Code
    HMM
    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
    HMM Distometer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HMM), ordered by most recent decision date.

    RULE, PUPILLARY

    FDA 510(k)
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