510(k) K070566 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jun 4, 2007 |
| Received | Feb 28, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2011 | Draeger Medical, Inc. Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms). Terminated |
MHX | None listed |
| Aug 22, 2011 | Draeger Medical Systems, Inc. Infinity Delta Portable Patient Monitor.
Draeger Medical Systems, Inc.
Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications Terminated |
MHX | None listed |
| Aug 22, 2011 | Draeger Medical Systems, Inc. Infinity Gamma X XL Portable Patient Monitor.
Draeger Medical Systems, Inc.
Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applica Terminated |
MHX | None listed |
| Aug 26, 2010 | Draeger Medical Systems, Inc. Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Terminated |
MHX | None listed |
| Aug 26, 2010 | Draeger Medical Systems, Inc. Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Terminated |
MHX | None listed |
| Dec 29, 2009 | Draeger Medical, Inc. Delta/Delta XL Monitors with Omega S Package Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.