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510(k) K251494

Eko Foundation Analysis Software with Transformers (EFAST) by Eko Health, Inc. — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2025
Date Received
May 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Electronic
Device Class
Class II
Regulation Number
870.1875
Review Panel
CV
Submission Type

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