MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System— 510(k) K230265

Substantially Equivalent

Infobionic, Inc.

FDA 510(k) clearance K230265 for MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System, Substantially Equivalent on 2023-10-06. Applicant: Infobionic, Inc..

Clearance details

Applicant: Infobionic, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2023-01-31
Decision date: 2023-10-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chelmsford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.