| K-number | K970215 |
| Device name | AUDALLION II HEARING SYSTEM |
| Applicant | Resound Corp. |
| Product code | ESD |
| Device class | Class I |
| Decision date | Mar 31, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 874.3300 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov