K253030
- 510(k) number
- K253030
- Device name
- Capnostream35 Portable Respiratory Monitor (PM35MN)
- Applicant
- Covidien, LLC CO · US
- Product code
- CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Decision date
- 2026-05-01
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253030.pdf
Official FDA record: K253030
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.