K233409

Substantially Equivalent

Eko Low Ejection Fraction Tool (ELEFT)

Applicant: Eko Health, Inc.
Product code: QYE
Advisory panel: Cardiovascular
Date received: 2023-10-06
Decision date: 2024-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emeryville, CA, US

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