MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER
Device Facts
| Record ID | K823126 |
|---|---|
| Device Name | MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER |
| Applicant | Electromedics, Inc. |
| Product Code | BZW · Anesthesiology |
| Decision Date | Nov 16, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1910 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.