Eko Analysis Software— 510(k) K192004

Name: FDA 510(k) clearance K192004
Creator: U.S. Food and Drug Administration
Published: 2020-01-15

Substantially Equivalent

Eko Devices, Inc.

FDA 510(k) clearance K192004 for Eko Analysis Software, Substantially Equivalent on 2020-01-15. Applicant: Eko Devices, Inc.. Device class: 2.

Clearance details

Applicant: Eko Devices, Inc.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
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 ↗

Recent devices under product code MWI

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K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from Eko Devices, Inc.

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K230111 — CORE 500 Digital Stethoscope2023-05-26
K213794 — Eko Murmur Analysis Software (EMAS)2022-06-29
K200776 — Eko CORE2020-04-06
K170874 — Eko Model E5 System (EME5), Eko DUO2017-05-19
K151319 — Eko Electronic Stethoscope System2015-08-28

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.