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

    FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10

    K Number: K853320 · Decision Sep 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    45
    Applicant Total
    5
    Review Days
    59

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    Basic Information

    Device Name
    FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10
    K Number
    K853320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3310
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Rastronics USA, Inc.
    Date Received
    July 30, 1985
    Decision Date
    September 27, 1985
    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 Rastronics USA, Inc.

    K Number Device Name
    K902244 RASTRONICS CCI 8
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    K902287 RASTRONICS PORTAREM 20
    K890864 HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.