K243092
- 510(k) number
- K243092
- Device name
- AcuPebble Ox (200)
- Applicant
- Acurable Limited GB
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2025-03-19
- Date received
- 2024-09-30
- 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: K243092.pdf
Official FDA record: K243092
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.