K012218 is an FDA 510(k) clearance for the LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES. This device is classified as a Pacemaker, Cardiac, External Transcutaneous (non-invasive) (Class II - Special Controls, product code DRO).
Submitted by The Ludlow Company LP (Chicopee, US). The FDA issued a Cleared decision on October 12, 2001, 88 days after receiving the submission on July 16, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5550.
| 510(k) Number | K012218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2001 |
| Decision Date | October 12, 2001 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRO — Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5550 |