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

    BTE HEARING AID CLUB MODEL: ST60

    K Number: K923294 · 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: ST60
    K Number
    K923294
    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
    K923296 BTE HEARING AID CLUB MODEL ST70
    K923293 ITC HEARING AID CLUB MODEL LM50H