510(k) K143114 ยท LQK Home Uterine Activity Monitor
Sense4Baby System Model B+ (MSA)
| Applicant | Airstrip Technologies, Inc., La Jolla CA, US |
| Decision | Substantially Equivalent, Mar 10, 2015 |
| Received | Oct 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2016 | AirStrip Technologies, Inc. AirStrip Sense4Baby Model C Fetal Monitor
The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is Terminated |
LQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.