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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?
    Applicant Name (Manufacturer) :

    KARMELSONIX

    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
    K101022
    Device Name
    PULMOTRACK 5050 WHOLTER, MODEL 5050
    Manufacturer
    KARMELSONIX
    Date Cleared
    2010-07-09

    (87 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KARMELSONIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulmoTrack 5050 Wholter™ is a non-invasive device intended to acquire, record and store ambulatory respiratory activity from patients for up to 24 hours. It works in concert with the PulmoTrack® Series for playback, review, analysis, editing and printing of respiratory data. The PulmoTrack 5050 Wholter™ is indicated for but not limited to recording of signals that reflect symptoms such as wheeze and cough.
    Device Description
    The PulmoTrack 5050 Wholter™ is a recording device of pulmonary sounds. The device collects the pulmonary data from 4 sensors including a sensor for ambient sounds to reduce background noise. The acquired data is filtered, undergoes A/D conversion and is stored on a flash disk. The digital data is later downloaded to a PC for analyzing using a diagnosis software package. The PulmoTrack 5050 Wholter™ device consists of: - . Acoustic sensors (attached to the patient using adhesive pads) - . Tension-sensitive respiration belt - . Ambient microphone - A/D data acquisition device . - . Firmware and Flash memory - . USB cable
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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?
    Applicant Name (Manufacturer) :

    KARMELSONIX

    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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