| Device Type ID | 78 |
| Device Name | Stethoscope, Esophageal, With Electrical Conductors |
| Regulation Description | Esophageal Stethoscope With Electrical Conductors. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.1920 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BZT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 78 |
| Device | Stethoscope, Esophageal, With Electrical Conductors |
| Product Code | BZT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Esophageal Stethoscope With Electrical Conductors. |
| CFR Regulation Number | 868.1920 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STARBOARD MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Incorrect Measurement | 2 |
Use Of Device Problem | 1 |
Electrical /Electronic Property Problem | 1 |
Device Inoperable | 1 |
Defective Component | 1 |
Low Readings | 1 |
Improper Device Output | 1 |
Output Problem | 1 |
Display Or Visual Feedback Problem | 1 |
Erratic Or Intermittent Display | 1 |
Temperature Sensor | 1 |
| Total Device Problems | 14 |