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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 Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type 510(K) Exempt
Regulation Number 870.1875
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    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 now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization 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 a requirement of the Modernization Act.
    Note: FDA intends to propose exempting these devices from premarket notification pursuant to the criteria at sections 510(l) and 510(m) of the FD&C Act, subject to limitations on exemption criteria found in .9 of the associated classification regulation. Until the publication of a final rule or order exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons