K121347 is an FDA 510(k) clearance for the PRESSON ELECTRODE. This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on July 12, 2012, 72 days after receiving the submission on May 1, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K121347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2012 |
| Decision Date | July 12, 2012 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXZ - Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |