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Found 49 results
510(k) Data Aggregation
K Number
K250322Device Name
Respond OC Conserving Regulator (130-0800)
Manufacturer
Responsive Respiratory
Date Cleared
2025-07-24
(170 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Product Code :
NFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K220591Device Name
Proxima
Manufacturer
Dynasthetics LLC
Date Cleared
2022-12-15
(289 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Product Code :
NFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.
Device Description
The Proxima Model-100 is an electronic oxygen conserving device designed for use in a hospital environment. It incorporates a sensitive pressure sensor to detect inhalation, an electronic valve to deliver precise volume of oxygen and a graphical touch screen interface. In pulsed mode the Proxima delivers flows equivalent to 1 to 15 liters per minute of continuous oxygen flow. The volume of each bolus is calculated such that the patient receives the equivalent of the set volume regardless of how slow their breath rate is. To make sure the patient receives oxygen, even if inhalation is not detected, the Proxima automatically changes from pulsed to continuous oxygen flow at the set flow rate if inhalation is not detected for 15 seconds. Proxima displays a warning message to indicate low battery, low oxygen supply pressure, dislodged cannula, lack of inhalation and low nasal airflow. The Proxima is powered using an external 9-volt DC power supply and includes an internal back-up battery. The Proxima is for use with a customer supplied, dual lumen demand nasal cannula, for example the Salter Labs 4807 or similar, to ensure proper patient usage.
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K Number
K221014Device Name
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
Manufacturer
Effortless Oxygen. LLC
Date Cleared
2022-10-17
(195 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Product Code :
NFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Effortless Oxygen Conserver Systems are intended to deliver medical-grade oxygen for patients that require supplemental oxygen from oxygen gas sources. Pulsing oxygen allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The Effortless MOBILE may be used in hospital, healthcare facilities, or home care environments. The Effortless PRO is only intended for hospital and healthcare facilities under professional use.
Device Description
The Effortless Oxygen Conserver Systems (EOCS) is a microprocessor-controlled device, which contains an oxygen pressure regulator and oxygen conserver. Depending upon the model they have been designed for use in ambulatory, home and medical facility settings to supply medical-grade oxygen therapy to patients. The built in oxygen regulator reduces oxygen pressures from an oxygen cylinder or from hospital wall supplies. There are two configurations: The Effortless Pro which connects to hospital wall oxygen and the Effortless Mobile which connects to tanks.
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K Number
K200401Device Name
Apogee
Manufacturer
Incoba Ltd. d/b/a Dynaris
Date Cleared
2020-11-14
(270 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Product Code :
NFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apogee is a gas conserver intended as a delivery device for medical grade oxygen from a high-pressure oxygen cylinders. Apogee is an ambulatory device which allows patients to ambulate longer than they would with continuous flow regulator on the same cylinder. The Apogee is intended to be used in the hospital, healthcare facilities, or home care environments.
Device Description
The proposed device, Apogee, senses each nostril independently through a bifurcated cannula and responds to the dynamic changes in nasal air-flow making a breath-to-breath determination of where to deliver the next bolus of oxygen: to the left, the right, or both nostrils. The Apogee Device is composed of the main components as detailed below: Control Unit, Control Board (Regulated Voltage Supply), Embedded Processor, User supplied Demand Cannula, The Apogee Bypass Cannula and Restrictor and Cylinder Tubing.
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K Number
K151506Device Name
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
Manufacturer
Salter Labs
Date Cleared
2016-03-11
(281 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Product Code :
NFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use is to deliver oxygen to the patient nasally, controlled by a demand system.
Device Description
The demand cannula is a special cannula designed to give adult and pediatric users of dual port oxygen conservation delivery system all the comfort and conveniences of a Salter-Style® cannula. Unique dual tubing delivers oxygen on demand through one tube while inspiratory / expiratory effort is also sensed through the other tube. Meets dual port device manufacturers' specifications.
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K Number
K131023Device Name
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
Manufacturer
MEDICAL PRODUCTS, LLC
Date Cleared
2013-10-11
(182 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Product Code :
NFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TheraFlow Oxygen Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for adult patients prescribed supplemental oxygen therapy for use inside the home or outside in ambulatory applications on patients with mobility. It is not intended for life support applications.
Device Description
Not Found
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K Number
K113111Device Name
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
Manufacturer
INOVO, INC.
Date Cleared
2011-12-08
(49 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Product Code :
NFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chad Therapeutics Evolution Model OM-900M is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 6 liters per minute, in their home and for ambulatory use.
Device Description
The Inovo Evolution OM-900M is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors control the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute depending on the user setting. The OM-900M is also able to detect motion via a 3 axis accelerometer. If motion is detected the software will automatically increase the oxygen delivery(active mode) to the patient. After motion has ceased, the software will then revert to the original rest setting(rest mode). The motion technology is taken from a previously cleared device Chad Sage Model TD-100 - K033364.
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K Number
K103392Device Name
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
Manufacturer
INOVO, INC.
Date Cleared
2010-12-17
(28 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Product Code :
NFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chad Therapeutics Evolution Model OM-900 is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 7 liters per minute, in their home and for ambulatory use
Device Description
The Inovo Evolution is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors convert the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 7 liters per minute depending on the flow rate setting
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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?
Product Code :
NFB
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
K070740Device Name
CHAD THERAPEUTICS BONSAI MODEL 800
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
2007-05-07
(52 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Product Code :
NFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chad Therapeutics Bonsai (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use.
Device Description
The Chad Therapeutics Bonsai a pneumatic-controlled device, which is a combination of r the Onad Therapoulator and an oxygen conserver, designed for use with ambulatory a low probute regulativers boluses of oxygen that is equivalent to 1 to 7 liters per minute, depending on the flow rate setting.
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