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

    SPIROMETER, MODEL TS-1000, PART NO. SLZ7504

    K Number: K860522 · Decision Mar 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    226
    Applicant Total
    13
    Review Days
    20

    Basic Information

    Device Name
    SPIROMETER, MODEL TS-1000, PART NO. SLZ7504
    K Number
    K860522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    TELEDYNE AVIONICS DIV. OF TELEDYNE
    Date Received
    February 11, 1986
    Decision Date
    March 3, 1986
    Product Code
    BZG
    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
    BZG Spirometer, Diagnostic

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