EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
K-Number: K240291 · 2024-04-08
ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2024-04-08
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2024-04-08 under approval number K240291. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM?
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2024-04-08. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K240291.
When was EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM approved by the FDA?
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM received FDA 510(k) clearance on 2024-04-08, under approval number K240291.
What company makes EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM?
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is manufactured by Ever Fortune.Ai, Co., Ltd..
What is the FDA product code for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM?
The FDA product code for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is QAS.
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Official Source
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