510(k) K180343 ยท POV Semen Analysis Device
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
| Applicant | Bonraybio Co., Ltd., Taichung, TW |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Feb 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180343
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.