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510(k) Data Aggregation
K Number
K052563Device Name
INOGEN SATELLITE CONSERVER, MODEL SC-100
Manufacturer
MEDICAL ELECTRONIC DEVICES, INC.
Date Cleared
2005-10-24
(35 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ELECTRONIC DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas as part of an oxygen delivery system including an oxygen concentrator, compressed oxygen cylinders, or liquid oxygen system.
Device Description
The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. The device is connected to an oxygen supply source and upon detecting the beginning of an inhalation; the device delivers a bolus of oxygen that is equivalent in most users, depending on the flow setting, to 1 to 5 liters per minute constant flow. The Inogen Satellite Conserver can be used with bottled oxygen systems and as an accessory to the Inogen One Oxygen Concentrator (K032818). The device uses these systems as its oxygen supply and is connected by an oxygen supply tube.
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K Number
K033197Device Name
INOGEN SATELLITE CONSERVER
Manufacturer
MEDICAL ELECTRONIC DEVICES, INC.
Date Cleared
2004-05-13
(224 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ELECTRONIC DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inogen Satellite Conserver is intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas and an oxygen concentrator.
Device Description
The Inogen Satellite Conserver intended to be used as an accessory to the Inogen One Oxygen Concentrator (K032818). The device uses the Inogen One Oxygen Concentrator as its oxygen supply and is connected by an oxygen supply tube. The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. Upon detecting the beginning of inhalation, the device delivers a bolus of oxygen that is equivalent in most users to 1 to 5 liters per minute constant flow, depending on the flow setting.
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K Number
K023420Device Name
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
Manufacturer
MEDICAL ELECTRONIC DEVICES, INC.
Date Cleared
2002-10-25
(14 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ELECTRONIC DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The modified Medical Electronic Devices Corp. POCD Pulsed Oxygen Conserving Device is intended for use in the same manner as the unmodified device, i.e., to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
Device Description
The Medical Electronic Devices Corp. POCDFR intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The POCDEe is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. It delivers boluses of oxygen every breath that is equivalent to 1 to 4 liters per minute constant flow, depending on the flow setting.
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K Number
K983601Device Name
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
Manufacturer
MEDICAL ELECTRONIC DEVICES, INC.
Date Cleared
1998-12-15
(62 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ELECTRONIC DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DOCD Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 0 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
The DOC Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and oxygen for paliente procente oxygen.
Device Description
The Demand Oxygen Conserving Device or "DOCD" is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The DOCD is a battery operated electronic device that is microprocessor controlled and contains a capacitive breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation opens the valve for 1 second and delivers the flow rate of oxygen set at the regulator to the patient. The valve closes and conserves the oxygen that would have been wasted during exhalation.
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K Number
K983459Device Name
PULSED OXYGEN CONSERVING DEVICE, POCD
Manufacturer
MEDICAL ELECTRONIC DEVICES, INC.
Date Cleared
1998-12-08
(69 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ELECTRONIC DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The POCD Pulsed Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
Device Description
The Pulsed Oxygen Conserving Device or "POCD" is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The POCD is a battery operated electronic device that is microprocessor controlled and contains a capacitive breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation opens the valve according to the device's breath skipping algorithm and delivers a preset bolus of oxygen to the patient. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.
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