myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)— 510(k) K193310

Substantially Equivalent

Abbott (St. Jude Medical)

FDA 510(k) clearance K193310 for myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS), Substantially Equivalent on 2020-03-17. Applicant: Abbott (St. Jude Medical).

Clearance details

Applicant: Abbott (St. Jude Medical)
Product code: Code MXC
Advisory panel: Cardiovascular
Date received: 2019-11-29
Decision date: 2020-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MXC

product code MXC

Death: 4
Injury: 758
Malfunction: 5,066
Total: 5,828

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.