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

    DISPOSABLE SURGICAL CABLE

    K Number: K941839 · Decision Jul 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    8
    Review Days
    105

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    Basic Information

    Device Name
    DISPOSABLE SURGICAL CABLE
    K Number
    K941839
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Conmed Andover Medical, Inc.
    Date Received
    April 13, 1994
    Decision Date
    July 27, 1994
    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 Conmed Andover Medical, Inc.

    K Number Device Name
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    K946273 1700 MONITORING ECG ELECTRODE
    K944726 1710 MONITORING ECG ELECTRODE
    K944655 ECG ELECTRODE
    K944849 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE
    K942718 CLOTH TENS/BNES ELECTRODE
    K942925 CONMED ANDOVER MED ECG ELECTRODES