K234090
- 510(k) number
- K234090
- Device name
- EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
- Applicant
- Surgvision GmbH DE
- Product code
- IZI — System, X-Ray, Angiographic
- Decision date
- 2024-03-20
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K234090.pdf
Official FDA record: K234090
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.