FDA 510(k) Applications Submitted by Inbal Ben Tzvi

FDA 510(k) Number Submission Date Device Name Applicant
K150095 01/16/2015 ReDs Wearable System SENSIBLE MEDICAL INNOVATIONS LTD.
K180479 02/22/2018 ReDS System Sensible Medical Innovations Ltd.
K231378 05/12/2023 Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 Insightec, Ltd.


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