The following data is part of a premarket notification filed by Stereo Optical Co., Inc. with the FDA for Vision Tester.
| Device ID | K843042 |
| 510k Number | K843042 |
| Device Name: | VISION TESTER |
| Classification | Refractometer, Ophthalmic |
| Applicant | STEREO OPTICAL CO., INC. 3539 NORTH KENTON Chicago, IL 60641 |
| Contact | Joseph Andera |
| Correspondent | Joseph Andera STEREO OPTICAL CO., INC. 3539 NORTH KENTON Chicago, IL 60641 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-02 |
| Decision Date | 1984-10-05 |