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Caption Health

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2022-01-19
TypeNumberDevice NameCodeDateActions
510(k) K210747 Caption Interpretation Automated Ejection Fraction SoftwareQIH2022-01-19 View
510(k) K201992 Caption GuidanceQJU2020-09-18 View
510(k) K200621 Caption Interpretation Automated Ejection Fraction SoftwareQIH2020-07-22 View
510(k) K200755 Caption GuidanceQJU2020-04-16 View

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