ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
Device Facts
| Record ID | K810147 |
|---|---|
| Device Name | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE |
| Applicant | Portex, Inc. |
| Product Code | BZT · Anesthesiology |
| Decision Date | Feb 5, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1920 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.