Onera STS 2 (ONERA STS 2)— 510(k) K243220

Substantially Equivalent

Onera B.V.

FDA 510(k) clearance K243220 for Onera STS 2 (ONERA STS 2), Substantially Equivalent on 2025-07-03. Applicant: Onera B.V..

Clearance details

Applicant: Onera B.V.
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2024-10-07
Decision date: 2025-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eindhoven, NL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.