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510(k) Data Aggregation
K Number
K202970Device Name
Ventway Sparrow
Manufacturer
Inovytech Medical Solutions Ltd.
Date Cleared
2021-01-29
(121 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
Inovytech Medical Solutions Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ventway Sparrow ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg ( 1 1b.), who require the following types of ventilatory support: SIMV VC PS, SIMV PC PS or CPAP.
The Ventway Sparrow lung ventilator is intended for emergency use and during transportation. It may be used for invasive (via an endotracheal tube and tracheostomy) or noninvasive (full non-vented ventilation face mask) ventilation presets. It may be used in hospital (transport) and field environments.
Models VWSP100MR and VWSP900MR may be used in a Magnetic Resonance (MR) environment up to 3 Tesla.
The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
Device Description
The Ventway Sparrow ventilator (a.k.a. Ventway Ventilator / Ventway System) is a portable ventilator, used for transport, in prehospital, field hospital, and hospital settings.
The ventilator is suitable for non-invasive ventilation for a full non-vented ventilation face mask or for invasive ventilation via an endotracheal tube or tracheostomy.
The Ventway is available in 2 models plus MR conditional use:
- . VWSP-100 Civil Model
- VWSP-100MR Civil Model ●
- VWSP-900 Robust Model ●
- VWSP-900MR Robust Model
The Ventway Sparrow consists of a ventilator unit with an LCD screen and a single use patient circuit.
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