K050350 is an FDA 510(k) clearance for the THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP). This device is classified as a Perimeter, Automatic, Ac-powered (Class I - General Controls, product code HPT).
Submitted by Notal Vision, Inc. (Rockville, US). The FDA issued a Cleared decision on April 29, 2005, 77 days after receiving the submission on February 11, 2005.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1605.
| 510(k) Number | K050350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2005 |
| Decision Date | April 29, 2005 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPT - Perimeter, Automatic, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1605 |