| Device Type ID | 861 |
| Device Name | Stethoscope, Manual |
| Regulation Description | Stethoscope. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.1875 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LDE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 861 |
| Device | Stethoscope, Manual |
| Product Code | LDE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Stethoscope. |
| CFR Regulation Number | 870.1875 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 1 |
Device Issue | 1 |
Defective Component | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 5 |