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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
K223347
UltraSight Inc.
UltraSight AI Guidance
07/24/2023
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