K860126 is an FDA 510(k) clearance for the STIMUPLEX, NERVE STIMULATOR. This device is classified as a Stimulator, Nerve, Battery-powered (Class II - Special Controls, product code BXN).
Submitted by Burron Medical Products, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 28, 1986, 45 days after receiving the submission on January 14, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K860126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1986 |
| Decision Date | February 28, 1986 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BXN — Stimulator, Nerve, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |