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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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