BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇰 Denmark

    BTE HEARING AID CLUB MODEL ST70

    K Number: K923296 · Decision Sep 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    5
    Review Days
    83

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    Basic Information

    Device Name
    BTE HEARING AID CLUB MODEL ST70
    K Number
    K923296
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Club Hearing Instruments A/S
    Date Received
    July 2, 1992
    Decision Date
    September 23, 1992
    Product Code
    ESD
    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
    ESD Hearing Aid, Air-Conduction, Prescription

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    Other Clearances by Club Hearing Instruments A/S

    K Number Device Name
    K923292 ITC HEARING AID CLUB MODEL LM50
    K923295 ITC HEARING AID CLUB MODEL LM40
    K923294 BTE HEARING AID CLUB MODEL: ST60
    K923293 ITC HEARING AID CLUB MODEL LM50H