EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
K-Number: K242821 · 2025-02-20
ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2025-02-20
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2025-02-20 under approval number K242821. 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 Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)?
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is a medical device that received FDA 510(k) clearance on 2025-02-20. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K242821.
When was EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) approved by the FDA?
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) received FDA 510(k) clearance on 2025-02-20, under approval number K242821.
What company makes EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)?
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is manufactured by Ever Fortune.Ai, Co., Ltd..
What is the FDA product code for EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)?
The FDA product code for EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is QAS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.