K234037
- 510(k) number
- K234037
- Device name
- CATS-L Tonometer Prism
- Applicant
- Cats Tonometer, LLC AZ · US
- Product code
- HKY — Tonometer, Manual
- Decision date
- 2024-02-09
- Date received
- 2023-12-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K234037.pdf
Official FDA record: K234037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.