FDA 510(k) Applications Submitted by Marc Bergenthal

FDA 510(k) Number Submission Date Device Name Applicant
K201632 06/16/2020 TOMTEC-ARENA TOMTEC Imaging Systems GmbH
K172259 07/27/2017 PulsioFlex Monitoring System PULSION Medical Systems SE
K223106 09/30/2022 Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) Brainlab AG
K213544 11/08/2021 TOMTEC-ARENA TOMTEC Imaging Systems GmbH


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