EFAI ChestSuite XR Pneumothorax Assessment System
K-Number: K221552 · 2022-11-08
ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2022-11-08
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EFAI ChestSuite XR Pneumothorax Assessment System is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2022-11-08 under approval number K221552. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EFAI ChestSuite XR Pneumothorax Assessment System?
EFAI ChestSuite XR Pneumothorax Assessment System is a medical device that received FDA 510(k) clearance on 2022-11-08. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K221552.
When was EFAI ChestSuite XR Pneumothorax Assessment System approved by the FDA?
EFAI ChestSuite XR Pneumothorax Assessment System received FDA 510(k) clearance on 2022-11-08, under approval number K221552.
What company makes EFAI ChestSuite XR Pneumothorax Assessment System?
EFAI ChestSuite XR Pneumothorax Assessment System is manufactured by Ever Fortune.Ai, Co., Ltd..
What is the FDA product code for EFAI ChestSuite XR Pneumothorax Assessment System?
The FDA product code for EFAI ChestSuite XR Pneumothorax Assessment System is QFM.
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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.