K251494

Substantially Equivalent

Eko Foundation Analysis Software with Transformers (EFAST)

Applicant: Eko Health, Inc.
Product 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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