K964644 is an FDA 510(k) clearance for the AD-TECH'S DEPTH 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 May 9, 1997, 190 days after receiving the submission on October 31, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K964644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1996 |
| Decision Date | May 09, 1997 |
| Days to Decision | 190 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 |