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510(k) Data Aggregation

    K Number
    K140179
    Device Name
    EASY GO VAC
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2014-04-25

    (91 days)

    Product Code
    BTA, REG
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easy Go Aspirator provides a portable, AC/DC powered medical vacuum source. It is intended for use in the homecare / health care environments.
    Device Description
    Small DC motor that powers a suction pump monitored by a gauge, vacuum is set by the care provider up to 21 inches of mercury. Uses an internal battery, with internal charger/power supply, on two models, and AC only on the third model.
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    K Number
    K103563
    Device Name
    PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2011-07-01

    (207 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical EasyPulse portable oxygen concentrator (model PM4150) is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device can be used in a home, institution, vehicle and for transportable use.
    Device Description
    The EasyPulse Portable Oxygen Concentrator (POC), model PM4150, was designed to provide supplemental oxygen to patients requiring oxygen therapy. The EasyPulse POC uses electronic conserving device technology to provide the patient with a lightweight, battery powered oxygen concentrator. The device can be used in the home, institution, vehicle and various mobile environments. A nasal cannula is used to channel oxygen from the device to the patient. The device is not intended to be life supporting or life sustaining. The EasyPulse POC provides pulsed dose delivery to the user through a selection of 5 settings. Setting 1 delivers the lowest amount of oxygen and setting 5 provides the highest. Minute volumes for each setting and oxygen concentration are listed in the device specifications. Oxygen minute volume is controlled electronically by monitoring the user's breath rate. By monitoring the user's breath rate the device is able to provide the patient the same amount of oxygen per minute. The EasyPulse POC offers the user multiple options to power the device. The device includes an internal Lithium-Ion battery, not accessible by the patient, that will provide varying runtimes dependent upon the setting chosen. Stated battery runtimes are listed in the specifications. An external AC/DC power supply is included with the device. The external AC/DC power supply allows the user to power the device from a standard 110 VAC outlet. An external DC/DC automobile adapter is also provided with the device. The external DC/DC automobile adapter allows the user to power the device from a standard 12V automobile accessory jack. When connected to either the AC/DC power supply or external DC/DC automobile adapter, the device will default to charging the internal battery when the unit is in the OFF position. If the unit is turned on while connected to either of the above, the device will simultaneously run (provide oxygen) and charge the internal battery.
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    K Number
    K103324
    Device Name
    PRECISION LIQUID OXYGEN SYSTEM
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2011-04-21

    (160 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical, Inc. Easy Mate 6 + 6 are intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. These patients would normally receive the oxygen via a nasal cannula. The systems delivers 100% oxygen at different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home.
    Device Description
    The Precision Medical, Inc. Easy Mate 6+6 consists of a Vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid Oxygen reservoir, where it is filled by a connection that allows the portable Device to be filled by the larger reservoir. The Precision Medical Inc Easy Mate 6+6 Is a mechanical device containing no electrical components.
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    K Number
    K090781
    Device Name
    HELIO2 BLENDER
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2009-08-13

    (143 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical, Inc. Heliox Blender Oxygen System is intended to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium. The blender is not intended as a life supporting device.
    Device Description
    The Precision Medical, Inc. Heliox/oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of Heliox/oxygen mixtures are required.
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    K Number
    K072348
    Device Name
    PRECISION OXYGEN CONCENTRATOR
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2008-10-27

    (433 days)

    Product Code
    CAW, REG
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The concentrator is intended for use in the home or hospital institutional environment.
    Device Description
    Precision Medical, Inc. Concentrator is a medical device that produces concentrated oxygen from room air. The concentrator uses a molecular sieve and a pressure differential absorption process to concentrate oxygen from air.
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    K Number
    K063096
    Device Name
    PRECISION OXYGEN MONITOR
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2007-02-27

    (140 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical Oxygen Monitor is intended to measure the concentration of oxygen being delivered to the patient. The oxygen monitor is not intended as a life supporting device.
    Device Description
    The Precision Medical, Inc. Oxygen monitor is made of two components, the monitor, and the sensor, attached by a coiled cable. The monitor houses the LCD screen, circuit board, key pad, and batteries. The sensor is a galvanic oxygen sensor that produces a millivolt signal that is proportional to partial pressure of oxygen being measured. The monitor converts the millivolt signal sent from the sensor to a percent oxygen concentration displayed on the LCD screen.
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    K Number
    K053232
    Device Name
    PRECISION BLENDER
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2006-01-10

    (53 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical, Inc. Blender Oxygen System is intended to deliver blended air and oxygen in a Hospital setting. Oxygen concentrations can be dialed in from 21% to 100%. The blender is not intended as a life supporting device.
    Device Description
    The Precision Medical, Inc. Air and Oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required.
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    K Number
    K051691
    Device Name
    MINIMATE COMPRESSOR
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2005-12-09

    (169 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical, Inc. Minimate compressor is intended to provide compressed air to a hand held medication small volume nebulizer. The device is not intended as a life supporting device.
    Device Description
    The compressor is made up of three basic sections - l. Electrical motor - 2. Compressor - 3. Housing. A 1/30 hp electrical motor drives the air compressor. The compressor is a piston type, which is self lubricating, thus providing a oil free, air supply to the nebulizer. The housing provides protection for the components, reduces noise, and dampens the vibration from the compressor. The housing also protects the end user from the components of the device.
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    K Number
    K041122
    Device Name
    PRECISION LIQUID OXYGEN SYSTEM
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2004-10-04

    (158 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical, Inc. Liquid Oxygen System is intended to provide supplemental oxygen to oxygen patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 4 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.
    Device Description
    The Precision Medical, Inc. Liquid Oxygen system consists of a vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid oxygen reservoir,where it is filled by a connection that allows the portable device to be filled by the larger reservoir. The Precision Medical Inc System is a mechanical device containing no electrical components.
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    K Number
    K032018
    Device Name
    EASY PULSE II OXYGEN CONSERVER
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2003-08-25

    (56 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 5 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.
    Device Description
    The Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 5 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.
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