K240847
- 510(k) number
- K240847
- Device name
- MedicCO2LON (MedicCO2LON)
- Applicant
- Ide Vision, Ltd. GB
- Product code
- FCX — Insufflator, Automatic Carbon-Dioxide For Endoscope
- Decision date
- 2024-10-30
- Date received
- 2024-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240847.pdf
Official FDA record: K240847
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.