K223863
- 510(k) number
- K223863
- Device name
- BONHAWA Respiratory Humidifier
- Applicant
- Telesair, Inc. CA · US
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2023-10-13
- Date received
- 2022-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K223863.pdf
Official FDA record: K223863
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.