EchoMeasure— 510(k) K241430

Substantially Equivalent

Icardio.Ai

FDA 510(k) clearance K241430 for EchoMeasure, Substantially Equivalent on 2024-10-10. Applicant: Icardio.Ai. Device class: 2.

Clearance details

Applicant: Icardio.Ai
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-05-21
Decision date: 2024-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Icardio.Ai

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