| K-number | K190561 |
| Device name | NICU V'02 |
| Applicant | Cosmed Nordic Aps |
| Product code | BZL |
| Device class | Class II |
| Decision date | Sep 4, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 868.1730 |
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