K243833
- 510(k) number
- K243833
- Device name
- Portable oxygen concentrator (JAY-1000P)
- Applicant
- Longfian Scitech Co., Ltd. CN
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2025-09-29
- Date received
- 2024-12-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243833.pdf
Official FDA record: K243833
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.