Chrysalis Intelligence
·
Sponsors
· Onera B.V.
Onera B.V.
Eindhoven, NL · 4 510(k) clearances
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Overview
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Total clearances
4
2022-04-06 → 2026-03-08
Last 12 months
1
Product codes
2
Most recent
2026-03-08
Trend
Clearance cadence
by quarter
Portfolio
Product codes
worked
Code
Device name
Class
Specialty
Clearances
Most recent
MNR
—
—
—
3
2025-07-03
OLZ
—
—
—
1
2026-03-08
Filings
All 510(k) clearances
(4)
Date
K-number
Device
Code
Class
Specialty
2026-03-08
K253668
Onera SleepMap (SLEEPMAP)
OLZ
—
—
2025-07-03
K243220
Onera STS 2 (ONERA STS 2)
MNR
—
—
2023-08-18
K223573
Onera Sleep Test System (Onera STS)
MNR
—
—
2022-04-06
K210593
Onera Sleep Test System (Onera STS)
MNR
—
—