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510(k) Data Aggregation

    K Number
    K063477
    Device Name
    NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
    Manufacturer
    NOVAMED, LLC
    Date Cleared
    2007-02-09

    (85 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaMed MRI Conditional laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
    Device Description
    The NovaMed MRI Conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.
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    K Number
    K062020
    Device Name
    LIFESOUND ESOPHAGEAL STETHOSCOPE
    Manufacturer
    NOVAMED, LLC
    Date Cleared
    2006-09-05

    (50 days)

    Product Code
    BZT
    Regulation Number
    868.1920
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use as an esophageal stethoscope to listen to patient heart and breathe sounds while a patient is under anesthesia or sedation. Optionally it may be used as a temperature sensor to monitor patient temperature. The electrical conductors are YSI 400 or 700 series compatible. They can be provided "clean, non-sterile" or "sterile".
    Device Description
    The NovaMed esophageal stethoscopes are long tubes which at the distal end have openings in the side wall and tip end. These openings are covered by a thin non-inflatable cuff to prevent secretions from entering in the distal end. A temperature sensor or electrical conductor can be placed inside the distal end with connecting wires running internally and exiting the proximal end of the stethoscope. The proximal end is fitted with a standard slip fit luer for connection to any standard earpiece or to the Lifesound electronic stethoscope (K844804). The insulated temperature sensor wires are terminated with standard connectors for fitting to standard cables which connect to the temperature monitor. They are available is various lengths, diameters (sizes), with or without temperature, and packaged clean, non-sterile and sterile.
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