K233200
- 510(k) number
- K233200
- Device name
- XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
- Applicant
- GEMSS HEALTHCARE CO., LTD. KR
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2023-11-16
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K233200.pdf
Official FDA record: K233200
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.