INTROSCOPE
Device Facts
| Record ID | K953793 |
|---|---|
| Device Name | INTROSCOPE |
| Applicant | Polamedco, Inc. |
| Product Code | BZT · Anesthesiology |
| Decision Date | Nov 29, 1995 |
| 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.
