K072736 is an FDA 510(k) clearance for the RHYTHMLINK INTERNATIONAL 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 January 22, 2008, 117 days after receiving the submission on September 27, 2007.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K072736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2007 |
| Decision Date | January 22, 2008 |
| Days to Decision | 117 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 |