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510(k) Data Aggregation
K Number
K980878Device Name
PULMOTRACK,MODEL 1010
Manufacturer
KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD.
Date Cleared
1998-12-28
(294 days)
Product Code
BZM
Regulation Number
868.1900Why did this record match?
Applicant Name (Manufacturer) :
KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD.
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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