Performance Hyperbarics · Class II · Cleared Nov 17, 2005
| K-number | K051759 |
| Device name | FLEXI-LITE, MODEL FL-V1.2 |
| Applicant | Performance Hyperbarics |
| Product code | CBF |
| Device class | Class II |
| Decision date | Nov 17, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 868.5470 |
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