K250322
- 510(k) number
- K250322
- Device name
- Respond OC Conserving Regulator (130-0800)
- Applicant
- Responsive Respiratory MO · US
- Product code
- NFB — Conserver, Oxygen
- Decision date
- 2025-07-24
- Date received
- 2025-02-04
- 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: K250322.pdf
Official FDA record: K250322
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.