K032799 is an FDA 510(k) clearance for the NON-CONTACT TONOMETERS, 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 January 20, 2004, 133 days after receiving the submission on September 9, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K032799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2003 |
| Decision Date | January 20, 2004 |
| Days to Decision | 133 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 |