K955031 is an FDA 510(k) clearance for the MAXISTIM. This device is classified as a Stimulator, Nerve, Peripheral, Electric (Class II - Special Controls, product code KOI).
Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on December 10, 1996, 404 days after receiving the submission on November 2, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K955031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1995 |
| Decision Date | December 10, 1996 |
| Days to Decision | 404 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | KOI — Stimulator, Nerve, Peripheral, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |