510(k) K240283 · FAJ Cystoscope And Accessories, Flexible/Rigid
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., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 10, 2024 |
| Received | Feb 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240283
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.