510(k) K191331 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Life Sensor Cardiac Monitor
| Applicant | Braveheart Wireless, Inc., Nashua NH, US |
| Decision | Substantially Equivalent, Jun 12, 2019 |
| Received | May 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191331
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.