Stereotaxis, Inc. · Class II · Cleared Aug 9, 2006
| K-number | K042850 |
| Device name | CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) |
| Applicant | Stereotaxis, Inc. |
| Product code | DQY |
| Device class | Class II |
| Decision date | Aug 9, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
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