K243220
- 510(k) number
- K243220
- Device name
- Onera STS 2 (ONERA STS 2)
- Applicant
- Onera B.V. NL
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2025-07-03
- Date received
- 2024-10-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243220.pdf
Official FDA record: K243220
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.