510(k) K093788 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Mar 8, 2010 |
| Received | Dec 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2021 | Draegar Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring Solution:
The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient Open, Classified |
MHX | None listed |
| Oct 31, 2019 | Draegar Medical Systems, Inc. The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372. Open, Classified |
MHX | None listed |
| Mar 11, 2013 | Draeger Medical, Inc. Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo)
Physiological patient monitoring system. Terminated |
MHX | None listed |
| Nov 22, 2011 | Draeger Medical, Inc. Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution
Networked solution/system used to monitor patients' vital signs and therapy, control alarms, Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.