FDA Clearance

Eko Foundation Analysis Software with Transformers (EFAST)

Submission
K251494
Type
510(k)
Company
Eko Health, Inc.
Decision Date
Aug 12, 2025
Specialty
Cardiovascular

Create a free account to keep reading

Free members get 10 full research views every month across publications, clinical trials, FDA clearances, adverse events, and NIH grants. No credit card required.

Want unlimited research access? See Pro plans

Data Accuracy Notice: Research intelligence on Health AI Central is aggregated from public sources (PubMed, ClinicalTrials.gov, FDA, NIH, CMS, and others) and refreshed nightly. Classifications and derived metrics are produced by automated methods described in our Methodology. We recommend verifying critical data points against the primary sources before making decisions.