K053550 is an FDA 510(k) clearance for the AMBU BLUE SENSOR NEO AND NEO X. This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on October 25, 2006, 309 days after receiving the submission on December 20, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K053550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2005 |
| Decision Date | October 25, 2006 |
| Days to Decision | 309 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRX — Electrode, Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2360 |