K232143
- 510(k) number
- K232143
- Device name
- Applanation Tonometer HT-5000
- Applicant
- Huvitz Co., Ltd. KR
- Product code
- HKY — Tonometer, Manual
- Decision date
- 2023-10-23
- Date received
- 2023-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232143.pdf
Official FDA record: K232143
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.