K971156 is an FDA 510(k) clearance for the KASHA VISUAL FIELD SYSTEM. This device is classified as a Perimeter, Automatic, Ac-powered (Class I - General Controls, product code HPT).
Submitted by Kasha Software, Inc. (Charlotte, US). The FDA issued a Cleared decision on May 28, 1997, 61 days after receiving the submission on March 28, 1997.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1605.
| 510(k) Number | K971156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1997 |
| Decision Date | May 28, 1997 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HPT — Perimeter, Automatic, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1605 |