The following data is part of a premarket notification filed by Notal Vision, Inc. with the FDA for The Notal Vision Preview Preferential Hyperacuity Perimeter (preview Php).
| Device ID | K050350 |
| 510k Number | K050350 |
| Device Name: | THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) |
| Classification | Perimeter, Automatic, Ac-powered |
| Applicant | NOTAL VISION, INC. 15825 SHADY GROVE RD., STE 30 Rockville, MD 20850 |
| Contact | Richard E Lippman |
| Correspondent | Richard E Lippman NOTAL VISION, INC. 15825 SHADY GROVE RD., STE 30 Rockville, MD 20850 |
| Product Code | HPT |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-11 |
| Decision Date | 2005-04-29 |
| Summary: | summary |