510(k) K131919— ZOLL EPCR IOS

Substantially Equivalent

ZOLL Medical Corporation

Clearance details

Applicant: ZOLL Medical Corporation
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2013-06-26
Decision date: 2013-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Chelsmford, MA, US

Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.