510(k) K193343 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
| Applicant | Vitalconnect, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Apr 20, 2020 |
| Received | Dec 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193343
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | Vitalconnect Inc. VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring syst Terminated |
DRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.