510(k) K210593

Onera Sleep Test System (Onera STS) by Onera B.V. — Product Code MNR

K210593 is an FDA 510(k) premarket notification submitted by Onera B.V. for the device "Onera Sleep Test System (Onera STS)". The FDA issued a decision of Substantially Equivalent on April 6, 2022. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Onera B.V. has at least 3 other 510(k) clearances on record.