Definition: The Lung Sound Monitor Is Intended For Use In Monitoring And Recording Lung Sounds.
| Device Type ID | 213 |
| Device Name | Lung Sound Monitor |
| 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 Description | Stethoscope. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Anesthesiology |
| 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 |
| CFR Regulation Number | 870.1875 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 213 |
| Device | Lung Sound Monitor |
| Product Code | OCR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stethoscope. |
| CFR Regulation Number | 870.1875 [🔎] |