The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Macular Function Analyzer.
| Device ID | K843227 |
| 510k Number | K843227 |
| Device Name: | MACULAR FUNCTION ANALYZER |
| Classification | Grid, Amsler |
| Applicant | DANEK MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HOQ |
| CFR Regulation Number | 886.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-16 |
| Decision Date | 1985-07-22 |