510(k) K141756 ยท MSX System, Network And Communication, Physiological Monitors
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Dec 12, 2014 |
| Received | Jun 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141756
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2019 | Draegar Medical Systems, Inc. Omega Systems
These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when us Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.