K903434 is an FDA 510(k) clearance for the SELECT NEUROMUSCULAR STIMULATORS. This device is classified as a Stimulator, Neuromuscular, External Functional (Class II - Special Controls, product code GZI).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 9, 1991, 374 days after receiving the submission on July 31, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K903434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 1990 |
| Decision Date | August 09, 1991 |
| Days to Decision | 374 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GZI — Stimulator, Neuromuscular, External Functional |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5810 |