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

FDA 510(k) Number Applicant Device Name Decision Date
DEN190040 Bay Labs, Inc. Caption Guidance 02/07/2020
K200755 Caption Health Caption Guidance 04/16/2020
K201992 Caption Health Caption Guidance 09/18/2020
K243065 Caption Health, Inc. Cardiac Guidance 01/15/2025
K242807 Deski HeartFocus (V.1.1.1) 04/04/2025
K223347 UltraSight Inc. UltraSight AI Guidance 07/24/2023


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