510(k) K113798 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Mar 22, 2012 |
| Received | Dec 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113798
| 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 28, 2018 | Draegar Medical Systems, Inc. Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4 Terminated |
MHX | None listed |
| Feb 21, 2018 | Draegar Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 404909805445 Terminated |
MHX | None listed |
| Oct 4, 2017 | Draegar Medical Systems, Inc. INFINITY DUAL HEMO MCable Pod Terminated |
MHX | None listed |
| Jun 6, 2017 | Draegar Medical Systems, Inc. Draeger Medical Systems Infinity Acute Care System (M540)
Catalog Numbers: MK31501/MK31701/MK31722 Terminated |
MHX | None listed |
| Jan 10, 2014 | Draeger Medical Systems, Inc. Draeger Infinity Acute Care System Monitoring Solution Terminated |
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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.