BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEARING AIDS (MODEL E-552 S-712)

    K Number: K761216 · Decision Dec 16, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    8
    Review Days
    9

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    Basic Information

    Device Name
    HEARING AIDS (MODEL E-552 S-712)
    K Number
    K761216
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Vicon Instrument Co.
    Date Received
    December 7, 1976
    Decision Date
    December 16, 1976
    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 Vicon Instrument Co.

    K Number Device Name
    K811751 FINETONE MODEL VI HEARING AID
    K790878 SCREENING AUDIOMETER, HIGH FREQUENCY
    K790064 TINNITUS DEVICES
    K771769 TINNITUS MASKERS, MODELS S564&S574
    K771762 MODULAR HEARING DEVICE, MODEL S291
    K770938 TINNITUS AID, MODEL S244
    K760215 HEARING AID, S-522 FM