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510(k) Data Aggregation

    K Number
    K181880
    Device Name
    VivaSight-SL (TVT) system
    Manufacturer
    ETView Ltd.
    Date Cleared
    2018-11-29

    (139 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETView Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral intubations. The VivaSight-SL (TVT) System is indicated for viewing during non-difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing and for general inspection of the airway.
    Device Description
    The ETView VivaSight-SL (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the VivaSight-SL (TVT™) is inside the patient's trachea.
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    K Number
    K181886
    Device Name
    VivaSight-DL System
    Manufacturer
    ETView Ltd.
    Date Cleared
    2018-11-14

    (124 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETView Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView VivaSight-DL is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The VivaSight-DL System is indicated for verifying tube placement and repositioning.
    Device Description
    The ETView VivaSight-DLTM System functions as a standard endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video image of the patient's bronchus, which is displayed on the monitor, for as long as the VivaSight-DL™ is inside the patient's bronchus. Visualization of the bronchus is used to verify placement and repositioning of the endobronchial tube during the intubation procedure or throughout surgery.
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    K Number
    K152438
    Device Name
    ETView VivaSight-SL (TVT) system
    Manufacturer
    ETVIEW LTD.
    Date Cleared
    2016-02-25

    (182 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETVIEW LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVT™) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The VivaSight-SL (TVT™) System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway. VivaSight-SL (TVT™) System is compatible for use with standard Laryngeal Mask Airway (LMA).
    Device Description
    The ETView VivaSight-SL (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the VivaSight-SL (TVTM) is inside the patient's trachea.
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    K Number
    K123853
    Device Name
    VIVASIGHT-DL SYSTEM
    Manufacturer
    ETVIEW LTD.
    Date Cleared
    2013-04-15

    (122 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETVIEW LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView VivaSight-DLTM System is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The VivaSight-DLTM System is indicated for verifying tube placement and repositioning.
    Device Description
    The ETView VivaSight-DLTM System functions as a standard endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video image of the patient's bronchus, which is displayed on the monitor, for as long as the VivaSight-DL™ is inside the patient's bronchus. Visualization of the bronchus is used to verify placement and repositioning of the endobronchial tube during the intubation procedure or throughout surgery.
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    K Number
    K121028
    Device Name
    ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
    Manufacturer
    ETVIEW LTD.
    Date Cleared
    2012-06-21

    (77 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETVIEW LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView Tracheoscopic Ventilation Tube (TVTM) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The TVT" System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway.
    Device Description
    The ETView Tracheoscopic Ventilation Tube (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the TVTTM is inside the patient's trachea.
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    K Number
    K120334
    Device Name
    VIVA EB
    Manufacturer
    ETVIEW LTD.
    Date Cleared
    2012-06-08

    (126 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETVIEW LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView Viva EB is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
    Device Description
    The ETView Viva EB is designed to administer one-lung ventilation, by using a conventional endotracheal tube and a fiber optic bronchoscope. The device consists of a bronchial blocker tube, advanced through an endotracheal tube, and a joint connector, connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
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    K Number
    K113576
    Device Name
    DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM
    Manufacturer
    ETVIEW LTD.
    Date Cleared
    2012-05-18

    (165 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETVIEW LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView Double Lumen Video Tracheoscope (DLVT™) is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The DLVT™ System is indicated for verifying tube placement and repositioning.
    Device Description
    The ETView Double Lumen Video Tracheoscope (DLVT™) System functions as a standard 37 French size endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video image of the patient's bronchus, which is displayed on the monitor, for as long as the DLVT™ is inside the patient's bronchus. Visualization of the bronchus is used to verify placement and repositioning of the endobronchial tube during the intubation procedure or throughout surgery. The device is indicated for non-MRI environment only.
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    K Number
    K082420
    Device Name
    TRACHEOSCOPIC VENTILATION TUBE (TVT)
    Manufacturer
    ETVIEW
    Date Cleared
    2008-10-08

    (47 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView Tracheoscopic Ventilation Tube (TVT™) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVT™) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The TVT™ System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.
    Device Description
    The ETView TVT™ is a single use, cuffed, endotracheal tube with an embedded video imaging device, and light source at its tip and integrated cable with connector to transfer the video signal to the display. The video image is displayed for as long as the Endotracheal tube (ETT) is inside the patient's trachea. The video image can be displayed on ETView's display or on most other TV/VCR displays. The ETView Tracheoscopic Ventilation Tube (TVT™) system consists of: - Endotracheal tube (ETT) with: . - Embedded Video camera o - Embedded Light source ం - Integrated cable with connector o - Monitor .
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    K Number
    K052233
    Device Name
    TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM
    Manufacturer
    ETVIEW LTD.
    Date Cleared
    2005-12-13

    (118 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETVIEW LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView Tracheoscopic Ventilation Tube (TVT) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The TVT System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.
    Device Description
    The ETView Tracheoscopic Ventilation Tube (TVT) System is a visualized endotracheal tube The ETV10 Pacelleosooped Pulmonx VETT System (K973191), except that the ETView System same as tiny CMOS video camera and light source and the Pulmonx device uses fiberoptic components.
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