The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Amblyopia Trainer.
| Device ID | K800112 |
| 510k Number | K800112 |
| Device Name: | AMBLYOPIA TRAINER |
| Classification | Device, Fixation, Ac-powered, Ophthalmic |
| Applicant | LIFE-TECH INSTRUMENTS, INC. 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 | 1980-01-16 |
| Decision Date | 1980-03-10 |