K100129 is an FDA 510(k) clearance for the AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR 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 June 11, 2010, 143 days after receiving the submission on January 19, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K100129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2010 |
| Decision Date | June 11, 2010 |
| Days to Decision | 143 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRX — Electrode, Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2360 |