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510(k) Data Aggregation

    K Number
    K052563
    Device Name
    INOGEN SATELLITE CONSERVER, MODEL SC-100
    Manufacturer
    MEDICAL ELECTRONIC DEVICES, INC.
    Date Cleared
    2005-10-24

    (35 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why 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
    K033197
    Device Name
    INOGEN SATELLITE CONSERVER
    Manufacturer
    MEDICAL ELECTRONIC DEVICES, INC.
    Date Cleared
    2004-05-13

    (224 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why 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
    K023420
    Device 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
    868.5905
    Why 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
    K983601
    Device 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
    868.5905
    Why 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
    K983459
    Device Name
    PULSED OXYGEN CONSERVING DEVICE, POCD
    Manufacturer
    MEDICAL ELECTRONIC DEVICES, INC.
    Date Cleared
    1998-12-08

    (69 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why 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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