K083148 is an FDA 510(k) clearance for the TELECTRODE WET GEL ECG ELECTRODE. This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by Bio Protech, Inc. (Woonju-Si, Gangwon-Do, KR). The FDA issued a Cleared decision on November 7, 2008, 14 days after receiving the submission on October 24, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K083148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2008 |
| Decision Date | November 07, 2008 |
| Days to Decision | 14 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 |