K231521
- 510(k) number
- K231521
- Device name
- Broncho Videoscope System
- Applicant
- Scivita Medical Technology Co., Ltd. CN
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2023-11-14
- Date received
- 2023-05-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K231521.pdf
Official FDA record: K231521
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.