K093825 is an FDA 510(k) clearance for the AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE. This device is classified as a Electrode, Needle, Diagnostic Electromyograph (Class II - Special Controls, product code IKT).
Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on January 13, 2010, 30 days after receiving the submission on December 14, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1385.
| 510(k) Number | K093825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2009 |
| Decision Date | January 13, 2010 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |