K240283
- 510(k) number
- K240283
- Device name
- BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
- Applicant
- MacroLux Medical Technology Co., Ltd. CN
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-06-10
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240283.pdf
Official FDA record: K240283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.