K111985 is an FDA 510(k) clearance for the MYOGUIDE SYSTEM MODEL 8008. This device is classified as a Stimulator, Nerve, Battery-powered (Class II - Special Controls, product code BXN).
Submitted by Intronix Technologies Corp. (Austin, US). The FDA issued a Cleared decision on December 30, 2011, 171 days after receiving the submission on July 12, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K111985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2011 |
| Decision Date | December 30, 2011 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BXN — Stimulator, Nerve, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |