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

    MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)

    K Number: K870255 · Decision Mar 26, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)
    K Number
    K870255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Transcor, Inc.
    Date Received
    January 22, 1987
    Decision Date
    March 26, 1987
    Product Code
    BZT
    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
    BZT Stethoscope, Esophageal, With Electrical Conductors

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    Other Clearances by Transcor, Inc.

    K Number Device Name
    K872234 TRANSCOR RADIO-STETHOSCOPE MB