The following data is part of a premarket notification filed by Design Research Assoc., Inc. with the FDA for Caliper-opthalmic.
| Device ID | K813315 |
| 510k Number | K813315 |
| Device Name: | CALIPER-OPTHALMIC |
| Classification | Caliper, Ophthalmic |
| Applicant | DESIGN RESEARCH ASSOC., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HOE |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-24 |
| Decision Date | 1982-03-01 |