Dideco · Class II · Cleared Oct 4, 2001
| K-number | K004001 |
| Device name | MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR |
| Applicant | Dideco |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Oct 4, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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