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510(k) Data Aggregation
K Number
K051550Device Name
INSPIRATION VENTILATOR SYSTEM
Manufacturer
EVENT MEDICAL LTD.
Date Cleared
2005-07-12
(29 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
EVENT MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.
Device Description
The Inspiration™ Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System, with the addition of the capability to set tidal volumes in volume targeted modes down to 5 ml, while 10 ml is the lower limit on the cleared device. This modification is implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration™ ventilator device.
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