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

    HEARING AID(ALL IN EAR)

    K Number: K852244 · Decision Nov 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    2
    Review Days
    168

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    Basic Information

    Device Name
    HEARING AID(ALL IN EAR)
    K Number
    K852244
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Olympia Instruments, Inc.
    Date Received
    May 23, 1985
    Decision Date
    November 7, 1985
    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 Olympia Instruments, Inc.

    K Number Device Name
    K896304 OLYMPIA FACEPLATE MODULE