K943939 is an FDA 510(k) clearance for the NON-CONTACT TONOMETER T-2. This device is classified as a Tonometer, Ac-powered (Class II - Special Controls, product code HKX).
Submitted by Canon, Inc. (Ohta-Ku, Tokyo, Japan, JP). The FDA issued a Cleared decision on May 12, 1995, 273 days after receiving the submission on August 12, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K943939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1994 |
| Decision Date | May 12, 1995 |
| Days to Decision | 273 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 |