K231778
- 510(k) number
- K231778
- Device name
- Nihon Kohden NKV-550 Series Ventilator System
- Applicant
- Nihon Kohden Orangemed, LLC CA · US
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2024-03-01
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231778.pdf
Official FDA record: K231778
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.