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510(k) Data Aggregation
K Number
K072469Device Name
DIGIFLO CONCENTRATOR ANALYZER
Manufacturer
DIGIFLO, INC.
Date Cleared
2008-01-03
(121 days)
Product Code
CCL
Regulation Number
868.1720Why did this record match?
Applicant Name (Manufacturer) :
DIGIFLO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DigiFLO Concentrator ANALYZER is a tool used by service personnel to measure Oxygen purity, Flow at the outlet of an oxygen concentrator. Also, it measures gas pressure inside and at the outlet of an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to a patient. The DigiFLO Concentrator ANALYZER is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.
Device Description
The DigiFLO Concentrator ANALYZER is a lightweight, battery operated device, which measures oxygen concentrator outlet oxygen gas concentration and flow rate by means of ultrasonic wave, which travels from one piezoelectric transducer to another, and Oxygen pressure by means of a piezoresistive pressure transducer. The device is a standalone product and does not have any accessories, power supply adapters and fittings. The device is intended as a tool for use by oxygen concentrator service personnel, to evaluate the output and internal pressures in an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to a patient.
The device connects to an oxygen concentrator through existing therapy tubing presently in use throughout the industry. The device is designed and calibrated for use only on the species gas mixture inherent with the output flow of a concentrator. Information provided by DigiFLO Concentrator ANALYZER is the concentrator's oxygen concentration, flow rate, and pressure. Continuous monitoring of output gas flow between an operating oxygen concentrator and the patient is not possible. Use with any downstream devices or patient accessories is also not possible.
It is further intended that this device be used on clean, dry and unhumidified concentrator output gas. In conjunction with the operating temperature of oxygen concentrators, the ambient temperature range of DigiFLO Concentrator ANALYZER is within +10 to +40 degrees Celsius and should remain in dry indoor environment.
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