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510(k) Data Aggregation
K Number
K090421Device Name
MODEL 350G GAS CONSERVER
Manufacturer
INSPIRED TECHNOLOGIES, INC.
Date Cleared
2009-05-29
(100 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
INSPIRED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inspired Technologies 350G Gas Conserver is intended as a delivery device for medial-grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device, which allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The 350G Gas Conserver is intended to be used in the hospital, healthcare facilities, or home care environments.
Device Description
The Inspired Technologies Model 350G Gas Conserver is designed to extend the use time of oxygen cylinders. It contains an integral pressure regulator with CGA 870 style yoke. The pressure regulator reduces the cylinder pressure to 19 - 25 psig. While the device is normally operated in the conserving mode, there is a continuous flow over-ride switch that allows 2 LPM of oxygen to bypass all valves for delivery to the patient. This continuous flow mode is typically used in the event of low or no battery power. In the conserving mode, the 350G Gas Conserver delivers oxygen to the patient by sensing inhalation via a pressure switch and opening one, two or both control valves for a specified period of time as determined by the microprocessor control algorithm. In the conserving mode, the device uses SmartDose™ technology to accomplish the oxygen savings. SmartDose™ senses the start of inhalation and releases a short "pulsed" dose at the very beginning of the inhalation cycle. The 350G Gas Conserver intended to be used by trained clinicians in the hospital, clinical or home care environments.
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K Number
K082853Device Name
CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
Manufacturer
INSPIRED TECHNOLOGIES, INC.
Date Cleared
2009-03-23
(175 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
INSPIRED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clinical Oxygen Dose Recorder (CODR) Model 300-CR records heart rate and oxygen saturation data provided by a Pulse oximeter; flow and pressure data from the oxygen delivery system; and measures breath rate and inhale/exhale ratio (1:E ratio) by monitoring the flow in the oxygen delivery tubing. Data is presented to enable the clinician to view the effects of the oxygen device's delivery performance on a patient in different ambulatory settings, i.e., rest and exercise. It is not to be used as a diagnostic tool.
The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments.
For the patient population the CODR will have the same indications for use as the oxygen source to which it is attached.
Device Description
The Inspired Technologies Clinical Oxygen Dose Recorder (CODR) Model 300 CR is a portable data gathering and information display system which is intended to be used as an adjunct to commercially available pulse oximetry and oxygen delivery systems to enable the clinician to record and view the gathered data together.
The CODR records heart rate and oxygen saturation data provided by a cleared Pulse Oximetry system, flow and pressure data from the oxygen delivery system, and tracks breath rate and inhale/exhale ratio (I:E ratio) by monitoring the flow in the oxygen delivery tubing. The CODR displays this data in real time to enable the clinician to view the effects of the oxygen device's delivery performance on a patient as they rest and exercise. It is not to be used as a diagnostic tool. The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments.
The CODR consists of two components; (1) an interface module and (2) PC based data display software.
1. The interface module is a portable, battery powered module which is in line with Oxygen Source and is used to connect various oxygen sources, including LOX portables, standard oxygen cylinders, and oxygen concentrators. Standard, commercially available, single or dual lumen nasal cannula can be used with the interface module. The CODR interface module also has capability of connecting a Pulse Oximeter. The interface module is designed to be worn by the patient during evaluation of the system. It is approximately 6" X 4" X 2" deep and contains the pressure and flow sensors, a connector for the pulse oximeter, and a Secure Digital (SD) card slot for use in data recording. The interface module is powered by four AA batteries. Either alkaline or rechargeable batteries can be used.
2. The PC based data display software
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