K243926
- 510(k) number
- K243926
- Device name
- Vivatmo pro-S
- Applicant
- Bosch Healthcare Solutions GmbH DE
- Product code
- MXA — System, Test, Breath Nitric Oxide
- Decision date
- 2025-09-11
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243926.pdf
Official FDA record: K243926
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.