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

    SPIROMETER, MODEL TS-500 PART #SLZ7534

    K Number: K855068 · Decision Feb 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    13
    Review Days
    49

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    Basic Information

    Device Name
    SPIROMETER, MODEL TS-500 PART #SLZ7534
    K Number
    K855068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Teledyne Avionics Div. of Teledyne
    Date Received
    December 18, 1985
    Decision Date
    February 5, 1986
    Product Code
    BTY
    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
    BTY Calculator, Predicted Values, Pulmonary Function

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    Other Clearances by Teledyne Avionics Div. of Teledyne

    K Number Device Name
    K860262 TA-6C - PART NUMBER SLZ 7520
    K860522 SPIROMETER, MODEL TS-1000, PART NO. SLZ7504
    K855070 SPIROMETER MODEL TS-200 SLZ 7541
    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
    Search all 13 clearances from Teledyne Avionics Div. of Teledyne →