BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    OVATION AGC-2

    K Number: K963818 · Decision Oct 28, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    6
    Review Days
    35

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    Basic Information

    Device Name
    OVATION AGC-2
    K Number
    K963818
    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
    Orsonique, Inc.
    Date Received
    September 23, 1996
    Decision Date
    October 28, 1996
    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 Orsonique, Inc.

    K Number Device Name
    K972373 OVATION HDP
    K963819 OVATION ASP
    K963820 OVATION LINEAR
    K963822 OVATION AGC-3
    K963821 OVATION AGC-1