K990015 is an FDA 510(k) clearance for the ELECTRODE NEEDLES. This device is classified as a Electrode, Needle, Diagnostic Electromyograph (Class II - Special Controls, product code IKT).
Submitted by Technomed Europe (6191 Bg Beek, NL). The FDA issued a Cleared decision on May 27, 1999, 143 days after receiving the submission on January 4, 1999.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1385.
| 510(k) Number | K990015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 1999 |
| Decision Date | May 27, 1999 |
| Days to Decision | 143 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 |