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

    IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE

    K Number: K950983 · Decision Apr 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    40

    Basic Information

    Device Name
    IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE
    K Number
    K950983
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4770
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INTROSPECT, INC.
    Date Received
    March 3, 1995
    Decision Date
    April 12, 1995
    Product Code
    ERA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERA Otoscope

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    Other Clearances by INTROSPECT, INC.

    K Number Device Name
    K951255 IMEDGE VIDEO OSTOSCOPE (ANALOG)