K243023
- 510(k) number
- K243023
- Device name
- WiZARD 520 Full Face Mask
- Applicant
- Wellell, Inc. TW
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2025-05-23
- Date received
- 2024-09-27
- 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: K243023.pdf
Official FDA record: K243023
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.