FDA 510(k) Applications Submitted by Marlene Fraga

FDA 510(k) Number Submission Date Device Name Applicant
K240174 01/23/2024 1688 4K Camera System with Advanced Imaging Modality Stryker Endoscopy
K220895 03/28/2022 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) Stryker
K222130 07/18/2022 1688 4K Camera System with Advanced Imaging Modality Stryker
K212511 08/10/2021 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) Stryker


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