K023816 is an FDA 510(k) clearance for the CANON FULL AUTO TONOMETER TX-F. This device is classified as a Tonometer, Ac-powered (Class II - Special Controls, product code HKX).
Submitted by Canon, Inc.-Utsunomiya Optical Products Operation (Lake Success, US). The FDA issued a Cleared decision on November 26, 2002, 11 days after receiving the submission on November 15, 2002.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K023816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2002 |
| Decision Date | November 26, 2002 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKX — Tonometer, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |