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

    TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100

    K Number: K904748 · Decision Mar 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    8
    Review Days
    133

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    Basic Information

    Device Name
    TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
    K Number
    K904748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Transtracheal Systems
    Date Received
    October 19, 1990
    Decision Date
    March 1, 1991
    Product Code
    DRG
    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
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

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    Other Clearances by Transtracheal Systems

    K Number Device Name
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    K981078 TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
    K981080 SCOOP 1
    K962944 TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
    K904749 TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200
    K902281 MODIFIED SCOOP TRANSTRACHEAL CATHETERS
    K854252 TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER