K051529 is an FDA 510(k) clearance for the AMBU NEUROLINE GROUND. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Ambu, Inc. (Glen Burnie, US). The FDA issued a Cleared decision on August 4, 2005, 56 days after receiving the submission on June 9, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K051529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2005 |
| Decision Date | August 04, 2005 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |