µCor Heart Failure and Arrhythmia Management System— 510(k) K172510

Substantially Equivalent

Zoll Manufacturing Corporation

FDA 510(k) clearance K172510 for µCor Heart Failure and Arrhythmia Management System, Substantially Equivalent on 2018-05-11. Applicant: Zoll Manufacturing Corporation.

Clearance details

Applicant: Zoll Manufacturing Corporation
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2017-08-21
Decision date: 2018-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.