Chrysalis Intelligence · Sponsors · Onera B.V.

Onera B.V.

Eindhoven, NL · 4 510(k) clearances

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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	Ventilatory Effort Recorder	Class II	Anesthesiology	3	2025-07-03
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Class II	Neurology	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	Class II	Neurology
2025-07-03	K243220	Onera STS 2 (ONERA STS 2)	MNR	Class II	Anesthesiology
2023-08-18	K223573	Onera Sleep Test System (Onera STS)	MNR	Class II	Anesthesiology
2022-04-06	K210593	Onera Sleep Test System (Onera STS)	MNR	Class II	Anesthesiology