K241447
- 510(k) number
- K241447
- Device name
- iCare ST500 (TA04)
- Applicant
- Icare Finland OY FI
- Product code
- HKY — Tonometer, Manual
- Decision date
- 2024-09-27
- Date received
- 2024-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241447.pdf
Official FDA record: K241447
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.