| K-number | K854537 |
| Device name | HEADSTRAP |
| Applicant | Life Design Systems, Inc. |
| Product code | BTK |
| Device class | Class I |
| Decision date | Dec 3, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 868.5560 |
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