510(k) K202089 ยท POV Semen Analysis Device
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
| Applicant | Bonraybio Co., Ltd., Taichung, TW |
| Decision | Substantially Equivalent, Oct 28, 2020 |
| Received | Jul 28, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202089
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.