Devices · Eko Health, Inc.

Eko Foundation Analysis Software with Transformers (EFAST)

Eko Health, Inc. is listed for Eko Foundation Analysis Software with Transformers (EFAST) (K251494). The FDA list gives August 12, 2025 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DQD. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251494

Official FDA database record

Date of final decision

August 12, 2025

Company on the FDA list

Eko Health, Inc.

Lead panel

Cardiovascular

Primary product code

DQD

openFDA device name for the code

Stethoscope, Electronic

Device class

2

Regulation number

870.1875

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary