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U.S. Department of Health and Human Services

Product Classification

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Device lung sound monitor
Regulation Description Stethoscope.
Definition The lung sound monitor is intended for use in monitoring and recording lung sounds.
Physical State The device consists of the arrays of electronic stethoscopes to collect the sound, a digital collector module, and is connected via cable to a PC workstation.
Technical Method Uses electronic stethoscopes placed in an array on the pts. back to record sounds within 100-250Hz, the sounds recorded are converted from analog to digital, and through software, displayed in a gray-scale image.
Target Area Posterior thorax to record sounds emanating from the lungs.
Regulation Medical Specialty Cardiovascular
Review Panel Anesthesiology
Product CodeOCR
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(K) Exempt
Regulation Number 870.1875
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible