510(k) K163694 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Rooti Rx ECG Event Recorder, Rooti Link APP Software
| Applicant | Rooti Labs , Ltd., Taipei, TW |
| Decision | Substantially Equivalent, Nov 7, 2017 |
| Received | Dec 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163694
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.