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

    D.L. SCOPE(R) OTOSCOPE

    K Number: K862661 · Decision Aug 8, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    55
    Applicant Total
    6
    Review Days
    25

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    Basic Information

    Device Name
    D.L. SCOPE(R) OTOSCOPE
    K Number
    K862661
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4770
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    North American Medical Products, Inc.
    Date Received
    July 14, 1986
    Decision Date
    August 8, 1986
    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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