K233933
- 510(k) number
- K233933
- Device name
- CIRRUS HD-OCT Model 6000
- Applicant
- Carl Zeiss Meditec, Inc. CA · US
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2024-05-17
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K233933.pdf
Official FDA record: K233933
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.