| K-number | K051724 |
| Device name | ACUMEN IMAGE GUIDED SURGICAL SYSTEM |
| Applicant | Ebi, L.P. |
| Product code | HAW |
| Device class | Class II |
| Decision date | Jul 19, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
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