K221900
- 510(k) number
- K221900
- Device name
- Stat Profile Prime Plus Analyzer System
- Applicant
- Nova Biomedical Corporation MA · US
- Product code
- CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And B
- Decision date
- 2023-09-29
- Date received
- 2022-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K221900.pdf
Official FDA record: K221900
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.