K252268
- 510(k) number
- K252268
- Device name
- V series portable oxygen concentrator (V5, V5C, V6, V6C)
- Applicant
- Shenzhen Harveymed Technology Co., Ltd. CN
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2025-12-16
- Date received
- 2025-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252268.pdf
Official FDA record: K252268
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.