510(k) K143359 ยท DSI Detector And Alarm, Arrhythmia
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
| Applicant | Lifewatch Technologies , Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, Sep 11, 2015 |
| Received | Nov 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143359
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.