K941865 is an FDA 510(k) clearance for the XPERT NCT. This device is classified as a Tonometer, Ac-powered (Class II - Special Controls, product code HKX).
Submitted by Reichert Ophthalmic Instruments, Div. Leica, Inc. (Depew, US). The FDA issued a Cleared decision on September 29, 1994, 164 days after receiving the submission on April 18, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K941865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 1994 |
| Decision Date | September 29, 1994 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HKX — Tonometer, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |