K250148
- 510(k) number
- K250148
- Device name
- Medical Gas Analyzer (AG200)
- Applicant
- Prior Care Science Technology, Ltd. CN
- Product code
- CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Decision date
- 2025-08-28
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250148.pdf
Official FDA record: K250148
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.