K062437 is an FDA 510(k) clearance for the DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED. This device is classified as a Electrode, Needle, Diagnostic Electromyograph (Class II - Special Controls, product code IKT).
Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on February 16, 2007, 189 days after receiving the submission on August 11, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1385.
| 510(k) Number | K062437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2006 |
| Decision Date | February 16, 2007 |
| Days to Decision | 189 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 |