BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODEL TM2-BEHIND-THE-EAR TINNITUS

    K Number: K792214 · Decision Nov 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    60
    Review Days
    25

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    Basic Information

    Device Name
    MODEL TM2-BEHIND-THE-EAR TINNITUS
    K Number
    K792214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Starkey Laboratories, Inc.
    Date Received
    November 2, 1979
    Decision Date
    November 27, 1979
    Product Code
    BWF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BWF Spirometer, Therapeutic (Incentive)

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