K071185 is an FDA 510(k) clearance for the MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE. This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on May 30, 2007, 30 days after receiving the submission on April 30, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K071185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2007 |
| Decision Date | May 30, 2007 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |