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510(k) Data Aggregation

    K Number
    K131881
    Device Name
    OMBRA TABLE TOP COMPRESSOR
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2013-10-24

    (121 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Product Code :

    BTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ombra® Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.
    Device Description
    The Ombra* Table Top Compressor provides a source of compressed air for use with jet nebulizers. The device is a motor-driven compressor, housed in a plastic case with rubber skids. It operates from 120V/60Hz. It is supplied with several replaceable air filters. The Ombra* Table Top Compressor is intended for adult, child and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
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    K Number
    K113338
    Device Name
    MEDICAL AIR COMPRESSOR
    Manufacturer
    ORICARE, INC.
    Date Cleared
    2012-08-10

    (270 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Product Code :

    BTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oricare C4500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator that operates within the C4500 Compressor manufacturer specifications.
    Device Description
    The Oricare C4500 Medical Air Compressor operates from an AC Voltage source and produces air from the normal environment supply compressed air for medical
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    K Number
    K091871
    Device Name
    DK50 DS
    Manufacturer
    EKOM S.R.O.
    Date Cleared
    2009-10-23

    (122 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Product Code :

    BTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for supplying compressed air for medical ventilators.
    Device Description
    The Ekom model DK50 DS is a portable air compressor designed to supply air to medical equipment, i.e., ventilators. The Model DK50 DS contain an oil-free piston compressor driven by a low maintenance single phase electric motor. Compressed air is cooled where condensed water is separated into a vessel. Incoming air passes through 2 filters and undergoes double filtration as it passes through the system. Constant output pressure is maintained by a pressure regulator. There is a built-in air tank which allows peak air consumption of 200 Lpm. The device may be used as a standby source of air. In this configuration, the respiratory equipment is supplied with compressed air from the facilities central air distribution. Air pressure in this central distribution is sensed by the Ekom pressure sensor. If the pressure is sufficient, the compressor stays in the STANDBY mode. If the pressure falls the compressor automatically starts and becomes the main air supply. When the compressor is used as the main source, the control unit determines its operation according to the current need for air. If air consumption is zero, the device switches to STANDBY. The compressor is equipped with indicators for output pressure, operation hours, power status, drying efficiency and battery condition as well as acoustic and optic alarms to warn of high operating temperature, low output pressure and loss power.
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    K Number
    K072634
    Device Name
    EMG TRITON -COMP,MODEL NCA01-XXX SERIES
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2008-11-19

    (428 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Product Code :

    BTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a portable air compressor intended to provide compressed air for medical purposes. It is used with a pneumatic nebulizer to administer humidified air or medication to the patient. The device is intended for use on adult and pediatric patients in a home health care or institutional environment. It's not approved for use with ventilators.
    Device Description
    The EMG TRITON-COMP. Is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital use. It is capable of servicing nebulizers and humidifiers to produce particle aerosol mist. The EMG TRITON-COMP. Powered by AC current (115V 60Hz) through the wall electric outlet at home, Maximum constant working pressure at 50psi, delivering up to 22LPM of flow (at pressure 10psi) and does not need software to drive. The outlet compressed air pressure of EMG TRITON-COMP. is produced through a built-in compressor. The consist parts include motor, cylinder, piston connecting rod, cup seal, eccentric crank, inlet valve, outlet valve ----etc. When turns on the compressor, motor starts to run and its shaft drives the eccentric crank to actuate the piston connecting rod moving up and down in the cylinder. When the piston is being in the down strike, a vacuum pressure is produced in the cvlinder, then the air will be sucked into the cylinder through an one-way inlet port. When the piston is being in the up strike, it presses out the air through the other outlet port to the atmosphere, these two one-way ports avoid the air being sucked from the atmosphere as well as the air in cylinder being pressed back to the inlet port. When motor keeps running, then the compressed air through outlet port is produced. One set of iron cover with protective earth encloses the compressor and wire harness to protect user from electrical shock and mechanical hurt hazard. The operating interface includes: a power switch, a compressed air pressure regulator, pressure gauge and air outlet port. The pressure regulator connected to the air outlet tube of compressor. The pressure gauge and the compressed air outlet port are connected to the pressure regulator through a three way connector and inner tube. Device's compressed air pressure can be adjusted by tuning the knob of pressure regulator, accuracy within +/-5%. The pressure gauge display the pressure data during operation.
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    K Number
    K060781
    Device Name
    MEDICAL COMPRESSOR, MODELS DK50 D AND DM
    Manufacturer
    EKOM S.R.O.
    Date Cleared
    2006-10-03

    (195 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Product Code :

    BTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators.
    Device Description
    The DK50 D and DK50 DM Medical Compressors are electric and produces air from the normal environment to supply compressed air for medical ventilators.
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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?
    Product Code :

    BTI

    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
    K041781
    Device Name
    VENTILAIR II MEDICAL AIR COMPRESSOR
    Manufacturer
    HAMILTON MEDICAL AG
    Date Cleared
    2005-03-14

    (256 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Product Code :

    BTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hamilton Medical VENTILAIR II is intended for use in hospitals and other institutions as an alternative to central air or cylinder air to supply medical air at 30 psi nominal to the GALILEO and the RAPHAEL models of Hamilton Medical ventilators which are intended to be operated with 30 psi nominal medical air supply. It can also be used as a backup medical air supply for these ventilators in case of failure of their normal air supply.
    Device Description
    The VENTILAIR II is an electromechanical and preumatic device only and has no software-based components. The device is rated at 115 V ± 10 %, 60 Hertz. It requires 466 Watts to power. The enclosure is designed to be mounted either on the GALILEO model or RAPHAEL model ventilator carts. Only one control is accessed during normal device operation, a power switch. The Power switch is switched ON both when the VENTILAIR II is configured and operated as a permanent air supply and when it is used as an emergency backup air supply. An indicator is provided to inform the user of the device performance status. This "Performance Gauge" is a pressure gauge calibrated for three zones of operation: Green (Normal Dry Operation), Yellow (Poor Drying Effect), and Red (Wet with Low Output Pressure). The VENTILAIR II has two air movements. The first is the cool, clean, dry compressed air movement that provides condensation-free compressed air to the ventilator. The second is the ambient air movement - an S-pattern that cools the entire drying system and compressor within the enclosure. The VENTILAIR II has been designed for easy maintenance. The compressor air intake filter element must be checked weekly. The 5 micron filter in the water trap must be replaced annually. Two internal pressure requlators and two other internal components must be checked annually and adjusted if necessary. Compressor overhaul is required periodically using the compressor manufacturer's overhaul kit. If the VENTILAIR II is used as an independent or continuous air source, an annual overhaul is recommended. If the compressor is used only as a backup in case of failure of the main air supply, overhaul is recommended every five years. All maintenance and overhaul procedures are described in the VENTILAIR II Operator's and Service Manuals. The VENTILAIR II is in full compliance with all required safety aspects of the current edition of IEC 60601-1. Several specific safety mechanisms have been incorporated into the VENTILAIR 11.
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    K Number
    K041406
    Device Name
    NEWPORT C250 AIR COMPRESSOR MODEL C250
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Date Cleared
    2004-12-15

    (203 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Product Code :

    BTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Newport C250 Air Compressor is designed and manufactured to supply a source of clean, oil-free pressurized air at 42 psig for use with the E100M, E150, E200, and e500 Newport Ventilators.
    Device Description
    The Newport C250 Air Compressor is electric and produces air from the normal environment to supply compressed air for Newport ventilators.
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    K Number
    K041974
    Device Name
    MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
    Manufacturer
    MED2000 S.R.L.
    Date Cleared
    2004-08-24

    (33 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Product Code :

    BTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MED2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, are ACpowered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model A1/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult or pediatric patients.
    Device Description
    These line powered piston compressors are housed in a plastic cabinet (case). The plastic cabinet is the only distinctive component between the three devices, that are identical for all other components, material and characteristics. Dimensions are 4.7 in. x 9.1 x 7.5 in. and weight 3.3 lbs. P3, P4 and P5 units contain no microprocessors or other electronic components. They operate from 115 VAC, 60 Hz. Each unit is supplied with an instruction manual and an accessory kit containing a nebulizer pediatric mask, a mouthpiece.
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    K Number
    K040220
    Device Name
    MEDICAL AIR COMPRESSOR
    Manufacturer
    EVENT MEDICAL LTD
    Date Cleared
    2004-06-09

    (128 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Product Code :

    BTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Independence™ Medical Air Compressor is indicated for use as a Medical Air Compressor providing compressed air to ventilators.
    Device Description
    The Independence™ Medical Air Compressor is a Class II device, "Portable Air Compressor'', per 21 CFR Part 868.6250. This device is designated a Class I. Type B equipment per IEC 60601-1. The Independence™ Medical Air Compressor is an air compressor for use in intensive care units or the recovery rooms of clinics, hospitals and hospital-type facilities which delivers filtered, oil-free and dehumidified compressed air to ventilators. Using the integrated backup function, the Independence™ Medical Air Compressor can be connected between an existing air supply network and a ventilator. If the compressed air from the air supply network fails, the Independence™ Medical Air Compressor automatically starts and supplies compressed air to the ventilator.
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