K232926
- 510(k) number
- K232926
- Device name
- Novalung ultimate kit (US)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- QJZ — Extracorporeal System For Long-Term Respiratory / Ca
- Decision date
- 2024-04-15
- Date received
- 2023-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232926.pdf
Official FDA record: K232926
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.