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

    ELECTRODE CABLE

    K Number: K880320 · Decision Mar 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    ELECTRODE CABLE
    K Number
    K880320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vital Connections, Inc.
    Date Received
    January 26, 1988
    Decision Date
    March 22, 1988
    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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    Other Clearances by Vital Connections, Inc.

    K Number Device Name
    K970755 STEALTHSHIELD