K250002
- 510(k) number
- K250002
- Device name
- Smart Check O2 (MA0236)
- Applicant
- Life Spark Medical, LLC UT · US
- Product code
- CCL — Analyzer, Gas, Oxygen, Gaseous-Phase
- Decision date
- 2025-04-24
- Date received
- 2025-01-02
- 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: K250002.pdf
Official FDA record: K250002
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.