K081756 is an FDA 510(k) clearance for the OCULAR RESPONSE ANALYZER. This device is classified as a Tonometer, Ac-powered (Class II - Special Controls, product code HKX).
Submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on August 7, 2008, 48 days after receiving the submission on June 20, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K081756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2008 |
| Decision Date | August 07, 2008 |
| Days to Decision | 48 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 |