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510(k) Data Aggregation
K Number
K081176Device Name
FLOCHANNEL
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
2008-07-28
(94 days)
Product Code
MNR, SUB
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FloCHANNEL is intended for use during sleep disorder studies to detect respiratory airflow onto a physiological recorder. A filtered disposable nasal/oral cannula attaches to the patient and connects into the input of the FloCHANNEL device. The outputs of the device provide low-voltage signals that are intended to be input into a physiological recorder.
The FloCHANNEL device can be used for pediatric patients, two years and older and adult patients including geriatric patients. The device is not intended for pediatrics and infants below two years of age for the purpose of respiration or SIDS monitoring.
Device Description
The FloCHANNEL, FC-100, Sleep Diagnostic Device accomplishes its intended purpose by providing a measure nasal airflow resistance effects. The device simultaneously measures relative airflow of isolated left, right, and oral passages. The FloCHANNEL, FC-100, provides analog voltage out hardware amplified analog voltages from three all now sensors, hardware analog voltages to aid in scoring the respiration of a patient. The outputs provided an have a summed output, and two microprocessor all now sensors, hardware analog voltages to aid in scoring the respiration of a patient.
The FloCHANNEL, FC-100, is dependent on the patient interface unit to be able to compute and detect the respiration patterns of the patient. This accessory is three air compute and delove the respirately pannula. The cannula is of one-piece construction that allows independent pneumatic fluid connection between the FloCHANNEL, FC-100, that the patient's left nasal airway, right nasal airway, and oral airway. The filter shall arra the patient of on habat all ways greater than or equal to 0.1 microns in size between prevent the transfer or partiountios groater and filter per channel on the patient interface unit with independently sealed chambers to prevent cross flow between pneumatic channels.
The FloCHANNEL has an output selection switch that is accessible from the outside of the enclosure and to a lour pockibility in the output options to be able to configure to a the switch to to ano it signal conditioners. With this switch there is the ability to create four different output voltage ranges.
There are six (6) output connectors on the FloCHANNEL, FC-100. All output connectors are Nort Julier. This re Nasal Processed Airflow, Oral Airway Processed Airflow, Sum r 10003500 Airflow and Right Nasal Processed Airflow, Relative Tidal Volume, and IE Marker.
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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?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
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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K Number
K042142Device Name
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
2004-09-20
(42 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chad Therapeutics Lotus (modified Chad Therapeutics OXYMATIC Model 411) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as a portable oxygen delivery system for patients who require supplemental oxygen at flow rates equivalent to 1 to 6 liters per minute, in their home and for ambulatory use.
Device Description
The Chad Therapeutics Lotus is a microprocessor-controlled device, which is a combination of a low-pressure regulator and an oxygen conserver, designed for use with a compressed oxygen source to provide a pulse of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting.
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K Number
K033364Device Name
CHAD THERAPEUTICS SAGE
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
2004-05-11
(203 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chad Therapeutics Sage is intended for prescription use only, to be used as part of a portable therapeutic oxygen system for patients that require supplemental oxygen while at rest or during activity.
Device Description
The Chad Therapeutics Sage is a microprocessor-controlled device, which is a combination of a low-pressure regulator and a therapeutic oxygen device, designed for use with ambulatory oxygen systems. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting and whether the user is at rest or active.
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K Number
K020475Device Name
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
2002-07-05
(143 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511 is intended 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 OXYPNEUMATIC CYPRESS Model 511 is a pneumaticcontrolled device, which is a combination of a low-pressure regulator and an oxygen conserver, designed for use with ambulatory oxygen systems. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting.
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K Number
K013472Device Name
TOTAL O2
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
2001-11-28
(41 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Chad Total O2 Delivery System is to supply low-pressure supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use. The oxygen supplied by the Total O2 Delivery System is supplemental and is not life supporting and not intended to be used with or for any life support applications or in the presence of flammable anesthetics.
The modified Chad Total O2™ Delivery System is intended for use in the same manner as the unmodified device: The Total O2™ Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.
Device Description
The Chad Total O2 Delivery System addresses several needs of patients and homecare providers. The Total O2 Delivery System has been designed to reduce the need for built storage and transport of liquid oxygen as well as the storage and transport of high-pressure oxygen gas cylinders for ambulatory use. The Total O2 Delivery System is comprised of conventional procedures and/or an integral pressure intensifier which supplies low pressure oxygen to a nasal cannula and/or an integral proposition of the oxygen gas cylinder for ambulatory use. The Total O2 Delivery System has a unique cylinder fill mechanism, which allows it to be easily, and safely connect to the patient's Total O2 oxygen cylinder. The unique cylinder fill mechanism ensures that Total O2 oxygen cylinders can only be filled by the Total O2 Delivery System. The Total O2 oxygen cylinders will be offered in two versions: 1. The original Total O2 cylinders with built in pressure reducer. 2. The Total O2 Post Valve cylinders with the same unique fill port as the original The Total O2, no built in pressure reducer but with a unique post valve outlet. The Total O2 post valve incorporates an internal mechanism to prevent filling the cylinders through the unique post valve port. Furthermore the Total O2 post valve would incorporate an index pin in the CGA V-1 number 13 position to prevent CGA-870 accordators, conserving devices, etc. from attaching to the unique post valve.
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K Number
K010389Device Name
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
2001-03-23
(42 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003455Device Name
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
2000-12-06
(29 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000890Device Name
CHAD THERAPEUTICS OXYMATIC MODEL 401
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
2000-06-16
(88 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K971889Device Name
CHAD TOTAL O2 DELIVERY SYSTEM
Manufacturer
CHAD THERAPEUTICS, INC.
Date Cleared
1997-11-17
(180 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
CHAD THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TOTAL O,TM Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.
Device Description
Not Found
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