K250670

Substantially Equivalent

EchoConfidence (USA)

Applicant: Mycardium AI Limited
Product code: QIH
Advisory panel: Radiology
Date received: 2025-03-05
Decision date: 2025-06-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Liverpool, GB

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Data sourced from openFDA. This site is unofficial and independent of the FDA.