K243767
- 510(k) number
- K243767
- Device name
- SV600, SV800 Ventilator
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. CN
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2025-08-28
- Date received
- 2024-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243767.pdf
Official FDA record: K243767
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.