510(k) K053484 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY GAMMA / GAMMAXL, INFINITY VISTA
| Applicant | Draeger Medical Systems, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Feb 22, 2006 |
| Received | Dec 15, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2006 | Draeger Medical, Inc. Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.