K243541
- 510(k) number
- K243541
- Device name
- LumiRex Bronchoscope
- Applicant
- Contra Healthcare Solutions, LLC PA · US
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2025-04-30
- Date received
- 2024-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243541.pdf
Official FDA record: K243541
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.