510(k) K012352 ยท POV Semen Analysis Device
SQA, SPERM QUALITY ANALYZER
| Applicant | Medical Electronic Systems, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Sep 21, 2001 |
| Received | Jul 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012352
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.