K231546
- 510(k) number
- K231546
- Device name
- Somfit
- Applicant
- Compumedics Limited AU
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2023-11-30
- Date received
- 2023-05-30
- 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: K231546.pdf
Official FDA record: K231546
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.