K232836
- 510(k) number
- K232836
- Device name
- Family of DIMAR DMAX NIV masks
- Applicant
- Dimar S.P.A. IT
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2024-08-14
- Date received
- 2023-09-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232836.pdf
Official FDA record: K232836
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.