| K-number | K854315 |
| Device name | HEARTECH MODEL IN TECH |
| Applicant | Hearing Tech, Inc. |
| Product code | ESD |
| Device class | Class I |
| Decision date | Jan 21, 1986 |
| 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