K240561
- 510(k) number
- K240561
- Device name
- Rugged Oxygen Generator (ROG) (RO01-00001)
- Applicant
- Molecular Products , Ltd. GB
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2024-12-06
- Date received
- 2024-02-29
- 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: K240561.pdf
Official FDA record: K240561
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.