K230178
- 510(k) number
- K230178
- Device name
- EasyOne Sky Spirometer
- Applicant
- Ndd Medizintechnik AG CH
- Product code
- BZG — Spirometer, Diagnostic
- Decision date
- 2023-10-19
- Date received
- 2023-01-23
- 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: K230178.pdf
Official FDA record: K230178
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.