K200984 is an FDA 510(k) clearance for the Guardian Needle 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 May 27, 2020, 43 days after receiving the submission on April 14, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K200984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2020 |
| Decision Date | May 27, 2020 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXZ - Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |