K131919 is an FDA 510(k) clearance for the ZOLL EPCR IOS. This device is classified as a Display, Cathode-ray Tube, Medical (Class II - Special Controls, product code DXJ).
Submitted by ZOLL Medical Corporation (Chelsmford, US). The FDA issued a Cleared decision on December 17, 2013, 174 days after receiving the submission on June 26, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2450.
| 510(k) Number | K131919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2013 |
| Decision Date | December 17, 2013 |
| Days to Decision | 174 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXJ — Display, Cathode-ray Tube, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2450 |