K230559
- 510(k) number
- K230559
- Device name
- Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
- Applicant
- Medline Industries, Inc. IL · US
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2023-10-26
- Date received
- 2023-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K230559.pdf
Official FDA record: K230559
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.