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

    TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM

    K Number: K952659 · Decision Jan 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    12
    Review Days
    213

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    Basic Information

    Device Name
    TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
    K Number
    K952659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tronomed, Inc.
    Date Received
    June 12, 1995
    Decision Date
    January 11, 1996
    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 Tronomed, Inc.

    K Number Device Name
    K853303 LIFELINC LEADWIRE
    K853452 LIFE LINC PATIENT CABLE
    K841092 HIGH PRESSURE FLEX. CONNECTING TUBING
    K792125 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE
    K792128 STERILE EXTENSION TUBES INDIV. PKG.
    K792124 TANDEM ASSEMBLED 3&4 WAY STOPCOCKS
    K792126 3&4 WAY PLASTIC STERILE STPCKS. PKG.
    K792127 PLAS. STCK. W/EXTENSION TUBE/STERILE
    K771645 ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE
    K771027 ELECTROCARDIOGRAPHIC PATIENT CABLES
    Search all 12 clearances from Tronomed, Inc. →