| K-number | K854263 |
| Device name | SETMA FHT, MODEL ST 8130 |
| Applicant | Setma, Inc. |
| Product code | ILJ |
| Device class | Class II |
| Decision date | Nov 13, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 890.5100 |
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