K251133
- 510(k) number
- K251133
- Device name
- AVEA disposable expiratory filter/water trap (11790)
- Applicant
- Telesair, Inc. CA · US
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2025-05-08
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251133.pdf
Official FDA record: K251133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.