BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    SENSORY 6

    K Number: K862338 · Decision Sep 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    75

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    Basic Information

    Device Name
    SENSORY 6
    K Number
    K862338
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5900
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Brytech, Inc.
    Date Received
    June 20, 1986
    Decision Date
    September 3, 1986
    Product Code
    HPG
    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
    HPG Aid, Vision, Electronic, Battery-Powered

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