K241268
- 510(k) number
- K241268
- Device name
- Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
- Applicant
- Exceleron Medical MN · US
- Product code
- BZE — Heater, Breathing System W/Wo Controller (Not Humidi
- Decision date
- 2024-08-02
- Date received
- 2024-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K241268.pdf
Official FDA record: K241268
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.