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

    CRITIKON #817 ESOPHAGEAL MULTI-PROBE

    K Number: K821890 · Decision Aug 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    51
    Review Days
    39

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    Basic Information

    Device Name
    CRITIKON #817 ESOPHAGEAL MULTI-PROBE
    K Number
    K821890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Critikon Company, LLC
    Date Received
    June 25, 1982
    Decision Date
    August 3, 1982
    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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