K234113
- 510(k) number
- K234113
- Device name
- MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
- Applicant
- Medimaging Integrated Solution, Inc (Miis) TW
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2024-05-01
- Date received
- 2023-12-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K234113.pdf
Official FDA record: K234113
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.