K091055 is an FDA 510(k) clearance for the RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R. This device is classified as a Electrode, Needle, Diagnostic Electromyograph (Class II - Special Controls, product code IKT).
Submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on June 23, 2009, 71 days after receiving the submission on April 13, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1385.
| 510(k) Number | K091055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2009 |
| Decision Date | June 23, 2009 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IKT - Electrode, Needle, Diagnostic Electromyograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1385 |