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510(k) Data Aggregation
K Number
K162877Device Name
VOCSN Unified Respiratory System
Manufacturer
VENTEC LIFE SYSTEMS, INC
Date Cleared
2017-04-07
(175 days)
Product Code
CBK, BTA, BZE, CAH, CAW, NHJ, NOU
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
VENTEC LIFE SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications.
The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.
Device Description
The VOCSN unified respiratory support system is a mechanical ventilator which combines additional conventional therapies into a single device. Additional therapies include oxygen, cough assist, and suction.
The device description will be broken down by therapy; i.e., ventilation, oxygen concentration and delivery, cough assist, and suction.
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