| 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 Code | OCR |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1875
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
|
Third Party Review
|
Accredited Persons
|
