K240215
- 510(k) number
- K240215
- Device name
- BLUE 400; BLUE 400 S
- Applicant
- Carl Zeiss Meditec, AG DE
- Product code
- QFX — Diagnostic Neurosurgical Microscope Filter
- Decision date
- 2024-06-28
- Date received
- 2024-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240215.pdf
Official FDA record: K240215
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.