MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System— 510(k) K160064

Substantially Equivalent

Infobionic, Inc.

FDA 510(k) clearance K160064 for MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System, Substantially Equivalent on 2016-03-11. Applicant: Infobionic, Inc..

Clearance details

Applicant: Infobionic, Inc.
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2016-01-13
Decision date: 2016-03-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lowell, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QYX

product code QYX

Death: 13
Malfunction: 526
Total: 539

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.