K251127
- 510(k) number
- K251127
- Device name
- PENTAX Medical Video Processor (EPK-i8020c)
- Applicant
- Pentax of America, Inc. NJ · US
- Product code
- PEA — Endoscope, Accessories, Image Post-Processing For Co
- Decision date
- 2025-06-03
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251127.pdf
Official FDA record: K251127
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.