K232860
- 510(k) number
- K232860
- Device name
- PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
- Applicant
- Pentax of America, Inc. NJ · US
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2024-01-18
- Date received
- 2023-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232860.pdf
Official FDA record: K232860
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.