The following data is part of a premarket notification filed by Stereo Optical Co., Inc. with the FDA for Optec 1000 Dmv.
| Device ID | K863509 |
| 510k Number | K863509 |
| Device Name: | OPTEC 1000 DMV |
| Classification | Chart, Visual Acuity |
| 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 | HOX |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-11-10 |