K812180 is an FDA 510(k) clearance for the LIFE-TECH #5102 VISULAB. This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).
Submitted by Life-Tech Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 21, 1981, 18 days after receiving the submission on August 3, 1981.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K812180 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1981 |
| Decision Date | August 21, 1981 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GWN — Nystagmograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1460 |