FDA 510(k) Applications for Medical Device Product Code "QNL"

FDA 510(k) Number Applicant Device Name Decision Date
K233253 AgileMD, Inc. eCARTv5 Clinical Deterioration Suite (ôeCARTö) 06/21/2024
K233216 Clew Medical Ltd. CLEWICU System 01/13/2024
K200717 CLEW Medical Ltd. CLEWICU System (ClewICUServer and ClewICUnitor) 01/09/2021
K231038 Edwards Lifesciences, LLC Global Hypoperfusion Index (GHI) Algorithm 07/26/2023
K230842 Implicity Inc. SignalHF (IM008) 10/25/2023


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