FDA 510(k) Applications Submitted by Efrat Shamgar

FDA 510(k) Number Submission Date Device Name Applicant
K220553 02/28/2022 Neuro Omega System, NeuroSmart System Alpha Omega Engineering Ltd.
K250601 02/28/2025 Neuro Omega System; NeuroSmart System Alpha Omega Engineering Ltd.
K211684 06/01/2021 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E Given Imaging Ltd. (Medtronic)


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