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510(k) Data Aggregation

    K Number
    K242736
    Device Name
    Portable Oxygen Concentrator (Spirit-3)
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., LTD.
    Date Cleared
    2025-06-05

    (267 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.
    Device Description
    Portable Oxygen Concentrator, model: Spirit-3, is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to deliver oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. Portable Oxygen Concentrator, model: Spirit-3, is capable of continuous use in a home, institutional, or travel environment. Power options include 100 – 240 V (50/ 60Hz) AC power supply, DC power supply and rechargeable lithium-ion battery. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories.
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    K Number
    K230702
    Device Name
    Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
    Manufacturer
    Qingdao Kingon Medical Science and Technology Co., Ltd.
    Date Cleared
    2023-10-18

    (218 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Concentrator (Model: P2-K4.P2-S4. P2-S3) is intended to provide supplemental oxygen in a home, institutional, or travel environment. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use with this device because of its pulse dose delivery mode.
    Device Description
    Portable Oxygen Concentrator (Model:P2-K4,P2-K3,P2-S4,P2-S3) is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.
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    K Number
    K223379
    Device Name
    Portable Oxygen Concentrator (Model: P2-E7, P2-E)
    Manufacturer
    Qingdao Kingon Medical Science and Technology Co., Ltd.
    Date Cleared
    2023-06-22

    (227 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Concentrator (Model: P2-E7, P2-E) is intended to provide supplemental oxygen in a home, institutional, or travel environment.
    Device Description
    Portable Oxygen Concentrator (Model: P2-E7, P2-E) is a portable oxygen generator that is intended to release oxygen for respiratory by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters. Model difference: The only different between model P2-E7 and P2-E is that P2-E7 has biggest output oxygen flow of 1.4L/min (at 7 gears) and P2-E has biggest output oxygen flow of 1.0L/min (at 5 gears).
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    K Number
    K191602
    Device Name
    APA Oxy Blade
    Manufacturer
    Venner Medical (Singapore) Pte Ltd
    Date Cleared
    2019-08-02

    (46 days)

    Product Code
    CCW
    Regulation Number
    868.5540
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.
    Device Description
    The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.
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    K Number
    K163412
    Device Name
    Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
    Manufacturer
    Girgis Scope LLC
    Date Cleared
    2017-06-22

    (199 days)

    Product Code
    CCW
    Regulation Number
    868.5540
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is indicated to improve direct visualization of larynx and assist in both non-complicated and difficult intubation of unpredictable airway condition.
    Device Description
    GSV200.DBL is designed to assist in tracheal intubation procedure by direct visualization of laryngeal anatomy in closed position and use movable blade with camera as accessory from different angle in open position. The physical shape of GSV200.DBL is a modification of traditional Macintosh blade similar to Propper flip tip laryngoscope with added movable blade with camera as accessory to provide visualization to insert endotracheal tube. Girgis Scope Video DBL is designed to use two power sources, one in the stationary handle for fiber optic illumination of the airway and the second in the DVR monitor to illuminate the Larynx for the video camera. Battery chargers, cables to computer and cable to connect to TV screen are accessories included in the kit. The GSV200.DBL is provided non-sterile and is reusable and can be disassembled to provide cleaning and disinfection.
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    K Number
    K140951
    Device Name
    YEESCOPE LARYNGOSCOPES
    Manufacturer
    YEESCOPE PTY. LTD.
    Date Cleared
    2014-11-10

    (210 days)

    Product Code
    CCW
    Regulation Number
    868.5540
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Yeescope laryngoscope is a single use, disposable laryngoscope blade and handle that is intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
    Device Description
    Yeescope laryngoscope blades and handles are single use, fully disposable laryngoscopes identical to our standard units except we have exchanged the battery to one that is less magnetic and thus would meet the requirements for MR conditional environments. Yeescope laryngoscope are offered in one (1) style and two (2) sizes; Macintosh style (curved) and in Sizes 3 and 4.
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    K Number
    K121378
    Device Name
    AIRTRAQ SP AIRTRAQ AVANT
    Manufacturer
    PRODOL MEDITEC LTD.
    Date Cleared
    2012-06-21

    (44 days)

    Product Code
    CCW
    Regulation Number
    868.5540
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Airtraq® SP - MR and Airtraq® Avant are intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
    Device Description
    Airtraq® Optical laryngoscope is an anatomical shaped rigid laryngoscope which allows the user to see the airway anatomy during insertion and intubation. It is designed with a guide channel in which one loads the endotracheal tube ("ET tube") that is then advanced once the glottis opening has been identified and centered in the view field of the Airtraq® optics. Prodol Meditec offers two (2) models. Airtraq® SP - single patient This model is a completely self-contained unit that operates on standard non-magnetic AAA batteries. It is a single patient use, disposable. Airtraq® Avant Avant once assembled is identical in its design and function as the Airtraq@ SP model. Avant is designed as 2 components unlike the Airtraq® SP model. 1. Optics This is a limited life reusable components which contains the lenses and mirrors of the optical system plus the rechargeable, non-magnetic battery, and PCB which controls the LED light, heater and diagnostics for the battery. 2. Blade There are 2 blade sizes, Regular (ET tube size 7.0 mm to 8.5 mm) and Small (ET tube 6.0 mm to 7.5 mm). These are single use disposables in which the Optics are inserted and then the assembled device used. There is an eye cap that incorporates a protective lens that fits over the Optics once it has been inserted into the Blade.
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    K Number
    K121167
    Device Name
    CAIRE COMPANION 5 OXYGEN CONCENTRATOR
    Manufacturer
    CAIRE INC.
    Date Cleared
    2012-05-02

    (15 days)

    Product Code
    CAW
    Regulation Number
    868.5440
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAIRE Companion 5, Oxygen Concentrator, is Intended for the administration of supplemental oxygen up to 5 liters/minute. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Device Description
    Not Found
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    K Number
    K063477
    Device Name
    NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
    Manufacturer
    NOVAMED, LLC
    Date Cleared
    2007-02-09

    (85 days)

    Product Code
    CCW
    Regulation Number
    868.5540
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaMed MRI Conditional laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
    Device Description
    The NovaMed MRI Conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.
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    K Number
    K062523
    Device Name
    TRU-MR LARYNGOSCOPE SET
    Manufacturer
    TRUPHATEK INTERNATIONAL, LTD.
    Date Cleared
    2006-11-17

    (81 days)

    Product Code
    CCW
    Regulation Number
    868.5540
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tru-MR TM laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
    Device Description
    The Truphatek Tru-MRTM MR conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.
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