BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ACAM 5 AUDIOMETER SYSTEM

    K Number: K103298 · Decision Apr 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    1
    Review Days
    151

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ACAM 5 AUDIOMETER SYSTEM
    K Number
    K103298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acousticon GmbH
    Date Received
    November 8, 2010
    Decision Date
    April 8, 2011
    Product Code
    EWO
    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
    EWO Audiometer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EWO), ordered by most recent decision date.

    OtoNova/OtoNova Pro

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Otoport Pro

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    hearOAE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Lyra

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GSI Corti

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all