The following data is part of a premarket notification filed by Triangle Investments with the FDA for Low Vision Enhancement System (lves).
| Device ID | K910124 |
| 510k Number | K910124 |
| Device Name: | LOW VISION ENHANCEMENT SYSTEM (LVES) |
| Classification | Aid, Vision, Electronic, Battery-powered |
| Applicant | TRIANGLE INVESTMENTS 1629 THAMES ST. 3RD FLOOR Baltimore, MD 21231 |
| Contact | Leigh R Abts |
| Correspondent | Leigh R Abts TRIANGLE INVESTMENTS 1629 THAMES ST. 3RD FLOOR Baltimore, MD 21231 |
| Product Code | HPG |
| CFR Regulation Number | 886.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-11 |
| Decision Date | 1991-04-10 |