K152984 is an FDA 510(k) clearance for the Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes. This device is classified as a Electrode, Needle, Diagnostic Electromyograph (Class II - Special Controls, product code IKT).
Submitted by Bio Protech, Inc. (Wonju-Si, KR). The FDA issued a Cleared decision on June 3, 2016, 238 days after receiving the submission on October 9, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1385.
| 510(k) Number | K152984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2015 |
| Decision Date | June 03, 2016 |
| Days to Decision | 238 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 |