510(k) K234032 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
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, Northfiled IL, US |
| Decision | Substantially Equivalent, Jun 4, 2024 |
| Received | Dec 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234032
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.