K251641
- 510(k) number
- K251641
- Device name
- GF-310R Multigas Unit (GF-310R)
- Applicant
- Nihon Kohden Corporation JP
- Product code
- CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Decision date
- 2026-08-12
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251641.pdf
Official FDA record: K251641
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.