K233225
- 510(k) number
- K233225
- Device name
- SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
- Applicant
- Schoelly Fiberoptic GmbH DE
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2024-06-20
- Date received
- 2023-09-28
- 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: K233225.pdf
Official FDA record: K233225
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.