Search Results
Found 3 results
510(k) Data Aggregation
K Number
K102229Device Name
PULMOTRACK 2020 SYSTEM
Manufacturer
KARMELSONIX
Date Cleared
2011-03-04
(207 days)
Product Code
BZM
Regulation Number
868.1900Why 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.
Ask a Question
K Number
K101022Device Name
PULMOTRACK 5050 WHOLTER, MODEL 5050
Manufacturer
KARMELSONIX
Date Cleared
2010-07-09
(87 days)
Product Code
DSH
Regulation Number
870.2800Why 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
Ask a Question
K Number
K090863Device Name
PERSONAL WHEEZOMETER
Manufacturer
KARMELSONIX
Date Cleared
2009-09-21
(175 days)
Product Code
BZM
Regulation Number
868.1900Why 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.
Ask a Question
Page 1 of 1