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

    WELCH ALLYN GLAUCOMA DETECTOR

    K Number: K941723 · Decision Jun 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    5
    Applicant Total
    111
    Review Days
    60

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    Basic Information

    Device Name
    WELCH ALLYN GLAUCOMA DETECTOR
    K Number
    K941723
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1605
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Welch Allyn, Inc.
    Date Received
    April 7, 1994
    Decision Date
    June 6, 1994
    Product Code
    HOO
    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
    HOO Perimeter, Ac-Powered

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