K233775
- 510(k) number
- K233775
- Device name
- Vivatmo pro
- Applicant
- Bosch Healthcare Solutions GmbH DE
- Product code
- MXA — System, Test, Breath Nitric Oxide
- Decision date
- 2024-02-22
- Date received
- 2023-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K233775.pdf
Official FDA record: K233775
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.