K231970
- 510(k) number
- K231970
- Device name
- PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock
- Applicant
- Pentax of America, Inc. NJ · US
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2024-01-12
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231970.pdf
Official FDA record: K231970
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.