K970418 is an FDA 510(k) clearance for the PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX). This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on April 29, 1997, 84 days after receiving the submission on February 4, 1997.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K970418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1997 |
| Decision Date | April 29, 1997 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZL — Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |