The following data is part of a premarket notification filed by Zeiss Humphrey System with the FDA for Instruments, Overrefraction System.
| Device ID | K782096 |
| 510k Number | K782096 |
| Device Name: | INSTRUMENTS, OVERREFRACTION SYSTEM |
| Classification | Instrument, Measuring, Lens, Ac-powered |
| Applicant | ZEISS HUMPHREY SYSTEM 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HLM |
| CFR Regulation Number | 886.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-18 |
| Decision Date | 1979-01-26 |