The following data is part of a premarket notification filed by Fite Engineering Corp. with the FDA for Fite Fixation Toy For Ocular Exam.
| Device ID | K801381 |
| 510k Number | K801381 |
| Device Name: | FITE FIXATION TOY FOR OCULAR EXAM |
| Classification | Device, Fixation, Ac-powered, Ophthalmic |
| Applicant | FITE ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HPL |
| CFR Regulation Number | 886.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-11 |
| Decision Date | 1980-07-28 |