510(k) K111215 ยท MSX System, Network And Communication, Physiological Monitors
ASCOM MOBILE MONITORING GATEWAY (MMG)
| Applicant | Ascom (Sweden) AB, Goteborg, SE |
| Decision | Substantially Equivalent, Jul 5, 2011 |
| Received | May 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111215
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2015 | Ascom US, INC. Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0). Terminated |
MSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.