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Found 8 results
510(k) Data Aggregation
K Number
K181880Device Name
VivaSight-SL (TVT) system
Manufacturer
ETView Ltd.
Date Cleared
2018-11-29
(139 days)
Product Code
BTR
Regulation Number
868.5730Why 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
K181886Device Name
VivaSight-DL System
Manufacturer
ETView Ltd.
Date Cleared
2018-11-14
(124 days)
Product Code
CBI
Regulation Number
868.5740Why 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
K152438Device Name
ETView VivaSight-SL (TVT) system
Manufacturer
ETVIEW LTD.
Date Cleared
2016-02-25
(182 days)
Product Code
BTR
Regulation Number
868.5730Why 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
K123853Device Name
VIVASIGHT-DL SYSTEM
Manufacturer
ETVIEW LTD.
Date Cleared
2013-04-15
(122 days)
Product Code
CBI
Regulation Number
868.5740Why 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
K121028Device Name
ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
Manufacturer
ETVIEW LTD.
Date Cleared
2012-06-21
(77 days)
Product Code
BTR
Regulation Number
868.5730Why 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
K120334Device Name
VIVA EB
Manufacturer
ETVIEW LTD.
Date Cleared
2012-06-08
(126 days)
Product Code
CBI
Regulation Number
868.5740Why 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
K113576Device Name
DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM
Manufacturer
ETVIEW LTD.
Date Cleared
2012-05-18
(165 days)
Product Code
CBI
Regulation Number
868.5740Why 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
K052233Device Name
TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM
Manufacturer
ETVIEW LTD.
Date Cleared
2005-12-13
(118 days)
Product Code
BTR
Regulation Number
868.5730Why 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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