Eko Analysis Software— 510(k) K192004

Substantially Equivalent

Eko Devices, Inc.

FDA 510(k) clearance K192004 for Eko Analysis Software, Substantially Equivalent on 2020-01-15. Applicant: Eko Devices, Inc..

Clearance details

Applicant: Eko Devices, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2019-07-26
Decision date: 2020-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.