510(k) K122337 ยท LHD Device, Fertility Diagnostic, Proceptive
OVUSENSE
| Applicant | Fertility Focus, Ltd., Swanee GA, US |
| Decision | Substantially Equivalent, Aug 6, 2013 |
| Received | Aug 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122337
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.