K240840
- 510(k) number
- K240840
- Device name
- Oxygen Concentrator (ZY-10AB/115)
- Applicant
- Foshan Care Medical Technology Co., Ltd. CN
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2024-12-06
- Date received
- 2024-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240840.pdf
Official FDA record: K240840
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.