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

    PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES

    K Number: K992524 · Decision Mar 1, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    1
    Review Days
    217

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    Basic Information

    Device Name
    PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
    K Number
    K992524
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advantage Medical Electronics, Inc.
    Date Received
    July 28, 1999
    Decision Date
    March 1, 2000
    Product Code
    DSA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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