Barrx Medical, Incorporated · Class II · Cleared Jun 29, 2005
| K-number | K051168 |
| Device name | BARRX HALO 360 SYSTEM, MODEL 1100C-115A |
| Applicant | Barrx Medical, Incorporated |
| Product code | GEI |
| Device class | Class II |
| Decision date | Jun 29, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 878.4400 |
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