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Etiometry, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K241479Etiometry Platform (DAV 5.4 RAE 9.2)February 12, 2025
K223578T3 Platform softwareJuly 7, 2023
K213423T3 Platform softwareJanuary 6, 2023
K213230T3 Platform SoftwareJune 22, 2022
K202306T3 Platform softwareNovember 25, 2020
K190273T3 Platform softwareDecember 8, 2019
K163065T3 SoftwareMay 26, 2017
K152258T3 SoftwareMarch 31, 2016
K151715T3 SoftwareOctober 29, 2015
K142732T3 SoftwareMarch 4, 2015