EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)— 510(k) K242821

Name: FDA 510(k) clearance K242821
Creator: U.S. Food and Drug Administration
Published: 2025-02-20

Substantially Equivalent

Ever Fortune.Ai, Co., Ltd.

FDA 510(k) clearance K242821 for EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100), Substantially Equivalent on 2025-02-20. Applicant: Ever Fortune.Ai, Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ever Fortune.Ai, Co., Ltd.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2024-09-18
Decision date: 2025-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

Download summary PDF View on FDA.gov ↗

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