BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    IONOS(R) OSSICLE 5MM & 7MM

    K Number: K911583 · Decision Sep 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    154

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    Basic Information

    Device Name
    IONOS(R) OSSICLE 5MM & 7MM
    K Number
    K911583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Ionos GmbH & Co. KG
    Date Received
    April 8, 1991
    Decision Date
    September 9, 1991
    Product Code
    ETA
    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
    ETA Replacement, Ossicular Prosthesis, Total

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