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Onera B.V.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253668Onera SleepMap (SLEEPMAP)March 8, 2026
K243220Onera STS 2 (ONERA STS 2)July 3, 2025
K223573Onera Sleep Test System (Onera STS)August 18, 2023
K210593Onera Sleep Test System (Onera STS)April 6, 2022