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

    VISTA EYESHOWER

    K Number: K971134 · Decision Nov 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    221

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    Basic Information

    Device Name
    VISTA EYESHOWER
    K Number
    K971134
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    John Branch
    Date Received
    March 28, 1997
    Decision Date
    November 4, 1997
    Product Code
    LXQ
    Advisory Committee
    Unknown
    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
    LXQ Cup, Eye

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