K252383
- 510(k) number
- K252383
- Device name
- Somfit D
- Applicant
- Compumedics Limited AU
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2025-08-28
- Date received
- 2025-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Flag
- Third-party review
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252383.pdf
Official FDA record: K252383
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.