K260171
- 510(k) number
- K260171
- Device name
- Portable Oxygen Concentrator (PO1 5B, PO1 6B)
- Applicant
- BMC Medical Co., Ltd. CN
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2026-08-14
- Date received
- 2026-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260171.pdf
Official FDA record: K260171
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.