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FDA 510(k) Applications Submitted by Ma Luisa Gomez de Aguero
FDA 510(k) Number
Submission Date
Device Name
Applicant
K221803
06/22/2022
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
SEDECAL SA
K192936
10/18/2019
Soltus 500
Sedecal., SA.
K203537
12/03/2020
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
SEDECAL SA
K161345
05/13/2016
RadPRO« Mobile 40kW; RadPRO« Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
SEDECAL SA
K173299
10/17/2017
DRAGON X SPSL4HC, DRAGON X SPSL8HC
Sedecal SA
K191813
07/05/2019
MobileDiagnost wDR 2.2
Sedecal SA
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