K234032
- 510(k) number
- K234032
- Device name
- Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line
- Applicant
- Medline Industries, LP IL · US
- Product code
- BZE — Heater, Breathing System W/Wo Controller (Not Humidi
- Decision date
- 2024-06-04
- Date received
- 2023-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K234032.pdf
Official FDA record: K234032
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.