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

    CORROSION PROOF DUAL PURPOSE ECG WIRES

    K Number: K802237 · Decision Oct 3, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    101
    Applicant Total
    2
    Review Days
    18

    Basic Information

    Device Name
    CORROSION PROOF DUAL PURPOSE ECG WIRES
    K Number
    K802237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    CUSTOM CARDIO COMPONENTS
    Date Received
    September 15, 1980
    Decision Date
    October 3, 1980
    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 CUSTOM CARDIO COMPONENTS

    K Number Device Name
    K802236 CORROSION PROOF SNAP ECG CONNECT WIRES