K112435 is an FDA 510(k) clearance for the RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on September 22, 2011, 29 days after receiving the submission on August 24, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K112435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2011 |
| Decision Date | September 22, 2011 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |