K840467 is an FDA 510(k) clearance for the NEUROMUSCULAR STIMULATOR 3105. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on February 17, 1984, 14 days after receiving the submission on February 3, 1984.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K840467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1984 |
| Decision Date | February 17, 1984 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |