EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM— 510(k) K240291
Substantially EquivalentEver Fortune.Ai, Co., Ltd.
FDA 510(k) clearance K240291 for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM, Substantially Equivalent on 2024-04-08. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
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Data sourced from openFDA. This site is unofficial and independent of the FDA.