K231813
- 510(k) number
- K231813
- Device name
- Ultrasonic Gastrovideoscope
- Applicant
- Sonoscape Medical Corp. CN
- Product code
- ODG — Endoscopic Ultrasound System, Gastroenterology-Urolo
- Decision date
- 2024-03-08
- Date received
- 2023-06-21
- 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: K231813.pdf
Official FDA record: K231813
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.