FDA 510(k) Applications Submitted by Raffi Werner

FDA 510(k) Number Submission Date Device Name Applicant
K220494 02/22/2022 BreathID Hp Lab System, BreathID Smart System Meridian Bioscience Israel Ltd.
K221896 06/30/2022 BreathID Hp System Meridian Bioscience Israel Ltd.
K162150 08/02/2016 BreathID Hp Lab System Exalenz Bioscience Ltd.
K223185 10/12/2022 BreathID« Smart System Meridian Bioscience Israel Ltd.
K173772 12/12/2017 BreathID Hp System Exalenz Bioscience Ltd.
K173777 12/12/2017 BreathID Hp Lab System Exalenz Bioscience Ltd.
K193610 12/26/2019 BreathID Smart System Exalenz Bioscience Ltd.


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