Onera B.V.

Onera B.V. — FDA 510(k) Submissions

Onera B.V. has submitted 4 FDA 510(k) premarket notifications since 2022, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilatory Effort Recorder, Automatic Event Detection Software For Polysomnograph With Electroencephalograph . Use the specialty filter in the sidebar to narrow results.