Eko Foundation Analysis Software with Transformers (EFAST)— 510(k) K251494
Substantially EquivalentEko 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.. Device class: 2.
Clearance details
- Applicant
- Eko Health, Inc.
- Product code
- Code DQD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Emeryville, CA, US
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