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510(k) Data Aggregation
K Number
K033897Device Name
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM
Manufacturer
AGA-LINDE HEALTH CARE
Date Cleared
2004-07-19
(216 days)
Product Code
ECX
Regulation Number
868.2700Why did this record match?
Applicant Name (Manufacturer) :
AGA-LINDE HEALTH CARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRIcompatible, and intended for use during MR imaging for MRI systems up to 3.0T.
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
Device Description
The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
The intearated system includes an aluminum cylinder, valve, requlator and flow meter. The device offers low flow settings that may be clinically appropriate for certain classes of patients.
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