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Ensodata
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K231355
Aurora
February 9, 2024
K210034
EnsoSleep
June 16, 2021
K162627
EnsoSleep
March 31, 2017