K241612
- 510(k) number
- K241612
- Device name
- Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd. CN
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2024-10-29
- Date received
- 2024-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K241612.pdf
Official FDA record: K241612
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.