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FDA 510(k) Applications for Medical Device Product Code "QNL"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K200717
CLEW Medical Ltd.
CLEWICU System (ClewICUServer and ClewICUnitor)
01/09/2021
K231038
Edwards Lifesciences, LLC
Global Hypoperfusion Index (GHI) Algorithm
07/26/2023
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