The following data is part of a premarket notification filed by Zeiss Humphrey System with the FDA for Objective Refractor.
| Device ID | K802029 |
| 510k Number | K802029 |
| Device Name: | OBJECTIVE REFRACTOR |
| Classification | Refractometer, Ophthalmic |
| Applicant | ZEISS HUMPHREY SYSTEM 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-21 |
| Decision Date | 1980-11-12 |