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

    MEDICAL SAFETY CABLE AND LEAD SYSTEM

    K Number: K912415 · Decision Aug 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    475
    Review Days
    77

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    Basic Information

    Device Name
    MEDICAL SAFETY CABLE AND LEAD SYSTEM
    K Number
    K912415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtronic Vascular
    Date Received
    May 31, 1991
    Decision Date
    August 16, 1991
    Product Code
    BZQ
    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
    BZQ Monitor, Breathing Frequency

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