ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE— 510(k) K110526

Substantially Equivalent

ZOLL Medical Corporation

FDA 510(k) clearance K110526 for ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE, Substantially Equivalent on 2011-03-25. Applicant: ZOLL Medical Corporation.

Clearance details

Applicant: ZOLL Medical Corporation
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2011-02-24
Decision date: 2011-03-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Chelsmford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.