510(k) K243220

Onera STS 2 (ONERA STS 2) by Onera B.V. — Product Code MNR

K243220 is an FDA 510(k) premarket notification submitted by Onera B.V. for the device "Onera STS 2 (ONERA STS 2)". The FDA issued a decision of Substantially Equivalent on July 3, 2025. 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.