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

    SPIROMETER MODEL TS-200 SLZ 7541

    K Number: K855070 · Decision Jan 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    89
    Applicant Total
    13
    Review Days
    43

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    Basic Information

    Device Name
    SPIROMETER MODEL TS-200 SLZ 7541
    K Number
    K855070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Teledyne Avionics Div. of Teledyne
    Date Received
    December 18, 1985
    Decision Date
    January 30, 1986
    Product Code
    BZC
    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
    BZC Calculator, Pulmonary Function Data

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    Other Clearances by Teledyne Avionics Div. of Teledyne

    K Number Device Name
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    K855069 SPIROMETER TS-400 SLZ 7547
    K854043 AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
    K851015 TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER
    K850461 AUTOMATIC IMPEDANCE METER TA-7A
    K844069 TA-201 CLINICAL AUDIOMETER
    K811509 AUTO-TYMPANIGRAPH (TA-5A)
    K801325 CLINICAL AUDIOMETER MODEL TA-200
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