K964312 is an FDA 510(k) clearance for the MENTOR TONO-PEN 3. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).
Submitted by Mentor Ophthalmics, Inc. (Norwell, US). The FDA issued a Cleared decision on November 26, 1996, 28 days after receiving the submission on October 29, 1996.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K964312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1996 |
| Decision Date | November 26, 1996 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKY — Tonometer, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |