510(k) K152407 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Infinity Delta, Infinity Delta XL, Infinity Kappa
| Applicant | Draeger Medical Sytems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Sep 23, 2015 |
| Received | Aug 25, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2019 | Draegar Medical Systems, Inc. Infinity Delta Family patient monitors
The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the param Open, Classified |
MHX | None listed |
| Mar 28, 2017 | Draegar Medical Systems, Inc. Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus.
Product Usage:
The devices are intended to be used in the environment where pat Terminated |
MHX | None listed |
| Mar 28, 2017 | Draegar Medical Systems, Inc. Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus.
Product Usage:
The devices are intended to be used in the environment where p Terminated |
MHX | None listed |
| Mar 28, 2017 | Draegar Medical Systems, Inc. Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853.
Product Usage:
The devices are inte Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.