K800484 is an FDA 510(k) clearance for the MOD. 3127 NEUROMUSCULAR STIMULATOR. 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 May 2, 1980, 59 days after receiving the submission on March 4, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K800484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1980 |
| Decision Date | May 02, 1980 |
| Days to Decision | 59 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 |