| K-number | K042109 |
| Device name | DIASYS INTEGRA II |
| Applicant | Novacor France |
| Product code | DXN |
| Device class | Class II |
| Decision date | Mar 9, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 870.1130 |
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