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510(k) Data Aggregation

    K Number
    K063309
    Device Name
    TRU-CABLE
    Manufacturer
    TRUPHATEK INTERNATIONAL, LTD.
    Date Cleared
    2007-01-12

    (71 days)

    Product Code
    FFS
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUPHATEK INTERNATIONAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tru-Cable™ endoscopic fiber optic cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adapted to be compatible with a variety of illuminators.
    Device Description
    The Truphatek Tru-Cable™ endoscopic fiber optic cables are: - . Lengths of 10 feet (3.5m) - Diameters 3.5mm and 5.0mm . - The fiber optic cable is hermetically sealed in a closed system so that it can be . sterilized or high level disinfected using most common methods. - The cables are sold non-sterile. . The fiber optic cables are designed for use with all the most popular light source illuminators and surgical instruments that are equipped with standard endoscopic adapters. They are designed for user high level disinfection and / or sterilization by autoclave or high level disinfection may be done via Steris® or Liquid Chemicals, i.e. Cidex OPA®. The cable is rated for 100 uses when processed via autoclave.
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    K Number
    K062523
    Device Name
    TRU-MR LARYNGOSCOPE SET
    Manufacturer
    TRUPHATEK INTERNATIONAL, LTD.
    Date Cleared
    2006-11-17

    (81 days)

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

    TRUPHATEK INTERNATIONAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tru-MR TM 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 Truphatek Tru-MRTM MR 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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