K243244
- 510(k) number
- K243244
- Device name
- Heated Breathing Tube
- Applicant
- Guangdong Eda Technology Co., Ltd. CN
- Product code
- BZE — Heater, Breathing System W/Wo Controller (Not Humidi
- Decision date
- 2025-07-25
- Date received
- 2024-10-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243244.pdf
Official FDA record: K243244
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.