K832800 is an FDA 510(k) clearance for the AUTOMATIC TANGENT SCREEN 50. This device is classified as a Perimeter, Ac-powered (Class I - General Controls, product code HOO).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on September 29, 1983, 42 days after receiving the submission on August 18, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1605.
| 510(k) Number | K832800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1983 |
| Decision Date | September 29, 1983 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOO — Perimeter, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1605 |