510(k) K191401 ยท LQK Home Uterine Activity Monitor
PregSense
| Applicant | Nuvo- Group , Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Mar 27, 2020 |
| Received | May 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191401
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.