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510(k) Data Aggregation
K Number
K122610Device Name
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
Manufacturer
SEN MU TECHNOLOGY CO., LTD.
Date Cleared
2013-08-05
(343 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
SEN MU TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PLAXTRON CPAP System is to provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment.
Device Description
The PLAXTRON CPAP System is a state of the art non-invasive, disposable ventilator support system. It is a venturi type oxygen / air mixture delivery device which provides CPAP pressure with a 50 PSI compressed gas source at a low input flow to a spontaneously breathing patient. The controlled airway pressure provides rapid relief for maximum patient benefit with minimal oxygen consumption. The device is low cost and completely disposable for single patient use and it is highly efficient to run from a low flow source for longer cylinder life. It equips with filters on inhalation and exhalation to provide maximum protection.
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