K232580
- 510(k) number
- K232580
- Device name
- Disposable Endobronchial Blocker Tube
- Applicant
- Shenzhen Insighters Medical Technology Co., Ltd. CN
- Product code
- CBI — Tube, Tracheal/Bronchial, Differential Ventilation (
- Decision date
- 2023-12-14
- Date received
- 2023-08-25
- 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: K232580.pdf
Official FDA record: K232580
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.