K944061 is an FDA 510(k) clearance for the CUEVA CRANIAL NERVE ELECTRODE. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on January 20, 1995, 154 days after receiving the submission on August 19, 1994.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K944061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1994 |
| Decision Date | January 20, 1995 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GZL — Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |