K862298 is an FDA 510(k) clearance for the ALTERNATE SIZE E-Z-PACE ELECTRODE. This device is classified as a Pacemaker, Cardiac, External Transcutaneous (non-invasive) (Class II - Special Controls, product code DRO).
Submitted by Medtronic Vascular (Lawrence, US). The FDA issued a Cleared decision on July 11, 1986, 24 days after receiving the submission on June 17, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5550.
| 510(k) Number | K862298 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1986 |
| Decision Date | July 11, 1986 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRO — Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5550 |