K863200 is an FDA 510(k) clearance for the COMPUTON(R). This device is classified as a Tonometer, Ac-powered (Class II - Special Controls, product code HKX).
Submitted by Optical Radiation Corp. (Azusa, US). The FDA issued a Cleared decision on September 3, 1986, 15 days after receiving the submission on August 19, 1986.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K863200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1986 |
| Decision Date | September 03, 1986 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HKX — Tonometer, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |