MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR— 510(k) K133753

Substantially Equivalent

Infobionic, Inc.

FDA 510(k) clearance K133753 for MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR, Substantially Equivalent on 2014-09-19. Applicant: Infobionic, Inc..

Clearance details

Applicant: Infobionic, Inc.
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2013-12-09
Decision date: 2014-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lowell, MA, US

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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.