K242736
- 510(k) number
- K242736
- Device name
- Portable Oxygen Concentrator (Spirit-3)
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. CN
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2025-06-05
- Date received
- 2024-09-11
- 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: K242736.pdf
Official FDA record: K242736
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.