510(k) K113441 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
PHYSIOLOGICAL MONITOR, PATIENT MONITOR
| Applicant | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Boeblingen, Baden-Wuerttemberg, DE |
| Decision | Substantially Equivalent, Mar 22, 2012 |
| Received | Nov 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2025 | Philips North America Llc Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Open, Classified |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.