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510(k) Data Aggregation

K Number

Device Name

Eko Foundation Analysis Software with Transformers (EFAST)

Manufacturer

Eko Health, Inc.

Date Cleared

2025-08-12

(89 days)

Product Code

Regulation Number

Type

Panel

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N/A

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Device Name :

Eko Foundation Analysis Software with Transformers (EFAST)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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