K992194 is an FDA 510(k) clearance for the CORTICAL MAPPING UNIT, MODEL CMU. This device is classified as a Electrode, Cortical (Class II - Special Controls, product code GYC).
Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on September 13, 1999, 76 days after receiving the submission on June 29, 1999.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1310.
| 510(k) Number | K992194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1999 |
| Decision Date | September 13, 1999 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYC — Electrode, Cortical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1310 |