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

    OPTUS OTOSCOPES

    K Number: K945264 · Decision Feb 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    55
    Applicant Total
    10
    Review Days
    462

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    Basic Information

    Device Name
    OPTUS OTOSCOPES
    K Number
    K945264
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4770
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Optus, Inc.
    Date Received
    October 28, 1994
    Decision Date
    February 2, 1996
    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 Optus, Inc.

    K Number Device Name
    K953913 OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES
    K945268 OPTUS BRONCHOSCOPES
    K945265 OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES
    K945262 OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
    K945267 OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
    K945266 OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K944656 OPTUS SINUSCOPES AND ACCESSORIES
    K945263 OPTUS THORACOSCOPES
    K945269 OPTUS LARYNGOSCOPES