K140502 is an FDA 510(k) clearance for the ZOLL E SERIES ALS. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II - Special Controls, product code LDD).
Submitted by ZOLL Medical Corporation (Chelsmford, US). The FDA issued a Cleared decision on November 6, 2014, 252 days after receiving the submission on February 27, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K140502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2014 |
| Decision Date | November 06, 2014 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDD — Dc-defibrillator, Low-energy, (including Paddles) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5300 |