| K-number | K240215 |
| Device name | BLUE 400; BLUE 400 S |
| Applicant | Carl Zeiss Meditec, AG |
| Product code | QFX |
| Device class | Class II |
| Decision date | Jun 28, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 882.4950 |
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