510(k) K152911 ยท BZQ Monitor, Breathing Frequency
EarlySense Insight Sytem
| Applicant | Earlysense, Ltd., Ramat Gan, IL |
| Decision | Substantially Equivalent, May 6, 2016 |
| Received | Oct 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152911
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.