K053011 is an FDA 510(k) clearance for the PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20. This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by Bio Protech, Inc. (Crofton, US). The FDA issued a Cleared decision on December 14, 2005, 49 days after receiving the submission on October 26, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K053011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2005 |
| Decision Date | December 14, 2005 |
| Days to Decision | 49 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 |