K233602
- 510(k) number
- K233602
- Device name
- P200TE (A10700)
- Applicant
- Optos Plc. GB
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2024-05-09
- Date received
- 2023-11-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K233602.pdf
Official FDA record: K233602
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.