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

    CAS (COMPUTERIZED ANALYZER SYSTEM)

    K Number: K896996 · Decision Aug 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    45
    Applicant Total
    10
    Review Days
    241

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    Basic Information

    Device Name
    CAS (COMPUTERIZED ANALYZER SYSTEM)
    K Number
    K896996
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3310
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Gn Danavox, Inc.
    Date Received
    December 11, 1989
    Decision Date
    August 9, 1990
    Product Code
    ETW
    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
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

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    Other Clearances by Gn Danavox, Inc.

    K Number Device Name
    K971032 DANAVOX MODELS 163/162 BTE
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    K924185 DFS GENIUS BTE
    K905692 143 SERIES BTE
    K905679 133 SERIES BTE
    K896995 DISCRETION, IN THE CANAL HEARING INSTRUMENT
    K891594 CERUMEN FILTER
    K863975 CUSTOM IN-THE-EAR