The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Pl 20/20 Infant Vision Tester.
| Device ID | K883337 |
| 510k Number | K883337 |
| Device Name: | PL 20/20 INFANT VISION TESTER |
| Classification | Chart, Visual Acuity |
| Applicant | OPTIMED TECHNOLOGIES, INC. 515 E. 22ND TERRACE P.O. BOX 3663 Lawrence, KS 66046 |
| Contact | Bonnie L Minkin,phd |
| Correspondent | Bonnie L Minkin,phd OPTIMED TECHNOLOGIES, INC. 515 E. 22ND TERRACE P.O. BOX 3663 Lawrence, KS 66046 |
| Product Code | HOX |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-09 |
| Decision Date | 1988-10-31 |