K970971 is an FDA 510(k) clearance for the URO MED NERVE STIMULATOR. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Uromed Corp. (Needham, US). The FDA issued a Cleared decision on October 27, 1997, 224 days after receiving the submission on March 17, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K970971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1997 |
| Decision Date | October 27, 1997 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |