K231355
- 510(k) number
- K231355
- Device name
- Aurora
- Applicant
- Ensodata WI · US
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2024-02-09
- Date received
- 2023-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231355.pdf
Official FDA record: K231355
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.