K813315 is an FDA 510(k) clearance for the CALIPER-OPTHALMIC. This device is classified as a Caliper, Ophthalmic (Class I - General Controls, product code HOE).
Submitted by Design Research Assoc., Inc. (Walker, US). The FDA issued a Cleared decision on March 1, 1982, 97 days after receiving the submission on November 24, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K813315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 1981 |
| Decision Date | March 01, 1982 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOE — Caliper, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |