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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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