K041026 is an FDA 510(k) clearance for the AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S. This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on June 28, 2004, 68 days after receiving the submission on April 21, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K041026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2004 |
| Decision Date | June 28, 2004 |
| Days to Decision | 68 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 |