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510(k) Data Aggregation

    K Number
    K102229
    Device Name
    PULMOTRACK 2020 SYSTEM
    Manufacturer
    KARMELSONIX
    Date Cleared
    2011-03-04

    (207 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Why did this record match?
    Product Code :

    BZM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulmoTrack TM 2020 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack TM 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds. The PulmoTrack TM 2020 is indicated for patient population above two years old
    Device Description
    The PulmoTrackTM 2020 is a computer based electronic stethoscope that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays, printed reports and automated identification of lung sounds. The data transfer may be done via Bluetooth wireless communication.
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    K Number
    K090863
    Device Name
    PERSONAL WHEEZOMETER
    Manufacturer
    KARMELSONIX
    Date Cleared
    2009-09-21

    (175 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Why did this record match?
    Product Code :

    BZM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PERSONAL WHEEZOMETER™ is intended for quantifying the presence of wheezing. This device should be used under the direction of a physician or licensed healthcare professional for monitoring acoustic pulmonary functions.
    Device Description
    The PERSONAL WHEEZOMETER™ ™ is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of wheczes. The device outputs a wheezerate score based on the amount of wheezing detected in a given time. The PERSONAL WHEEZOMETER™ (PW) is intended to be a home use version of the PulmoTrack® (K980878) and PulmoTrack model 2010 (WIM-PC) (k071955), providing wheeze-rate information for both home and clinical settings. The PERSONAL WHEEZOMETER™ device consists of: - An acoustic contact sensor - An air-coupled electret microphone for ambient noise rejection module. - LCD screen to display measurement results - 4 user buttons - Signal conditioning and digitization PCB - Dedicated DSP - SDRAM memory - Embedded software.
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    K Number
    K071955
    Device Name
    WIM-PC, MODEL 1010
    Manufacturer
    KARMEL SONIX
    Date Cleared
    2007-11-01

    (108 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Why did this record match?
    Product Code :

    BZM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.
    Device Description
    The WIM-PC™ is a computer based electronic stethoscope that utilizes two contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports. The WIM-PCTM system consists of: Acoustic sensors (attached to the patient using adhesive pads), Sensor pod with a built-in dielectric microphone for ambient noise pick-up, Tension-sensitive respiration belt, A/D data acquisition device, USB cable and signal cable, Laptop PC unit with Data Analysis software.
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    K Number
    K012387
    Device Name
    STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
    Manufacturer
    STETHOGRAPHICS, INC.
    Date Cleared
    2002-04-23

    (270 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Why did this record match?
    Product Code :

    BZM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel.
    Device Description
    The Stethographic STG Monitor Multichannel Lung Sound Analysis System Comprises Chest pad with electronic stethoscopes, back pad, pre-amplifier, connection hub, and a PC computer. The system also includes a printer, a cart, speakers, headphones, re-writable CDs for data storage and custom software. The system is non-invasive with patient contact disposable cotton cover.
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    K Number
    K980878
    Device Name
    PULMOTRACK,MODEL 1010
    Manufacturer
    KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD.
    Date Cleared
    1998-12-28

    (294 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Why did this record match?
    Product Code :

    BZM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulmoTrack Model 1010 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack Model 1010 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in a pulmonary function testing environment when there is a need to perform an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.
    Device Description
    The PulmoTrack is a computer based electronic stethoscope that utilizes up to five contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports.
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    K Number
    K974200
    Device Name
    ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM
    Manufacturer
    ORCA DIAGNOSTICS CORP.
    Date Cleared
    1998-07-21

    (253 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Why did this record match?
    Product Code :

    BZM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORCA System is indicated for use in exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the results of the analysis and the reasons for the test termination. The intended patients are adults and children and the intended environment of use is indoors.
    Device Description
    The ORCA Cardiopulmonary Exercise Testing System is a self-contained unit designed to provide patient respiratory gas exchange data during exercise stress testing. The system consists of components which measure the flow of exhaled air, and analyze the oxygen and carbon dioxide content of the exhaled air. A transcutaneous pulse oximeter reports heart rate and oxygen content of the arterial blood. Instruments are interfaced to a Pentium-based personal computer through a 16 channel, 12 bit analog/digital converter. As an option, information can be integrated with electrocardiographic information provided by external EKG equipment (EKG equipment is not provided with the ORCA system). Software collects and analyzes data, summarizes results and suggests possible implications of abnormalities observed.
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    K Number
    K955432
    Device Name
    CPX, CCM, CATH WITH 15% CO2
    Manufacturer
    MEDICAL GRAPHICS CORP.
    Date Cleared
    1996-07-01

    (216 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Why did this record match?
    Product Code :

    BZM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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