Eko Foundation Analysis Software with Transformers (EFAST)— 510(k) K251494

Substantially Equivalent

Eko Health, Inc.

FDA 510(k) clearance K251494 for Eko Foundation Analysis Software with Transformers (EFAST), Substantially Equivalent on 2025-08-12. Applicant: Eko Health, Inc..

Clearance details

Applicant: Eko Health, Inc.
Product code: Code DQD
Advisory panel: Cardiovascular
Date received: 2025-05-15
Decision date: 2025-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emeryville, CA, US

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