K231414
- 510(k) number
- K231414
- Device name
- CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
- Applicant
- Chalice Medical , Ltd. GB
- Product code
- DTZ — Oxygenator, Cardiopulmonary Bypass
- Decision date
- 2023-11-01
- Date received
- 2023-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231414.pdf
Official FDA record: K231414
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.