The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Patient Monitor Mx100, Intellivue Multi-measurement Module X3, Intellivue Microstream Extension.
| Device ID | K181314 |
| 510k Number | K181314 |
| Device Name: | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 Boeblingen, DE 71034 |
| Contact | Stefan Breuer |
| Correspondent | Stefan Breuer Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 Boeblingen, DE 71034 |
| Product Code | MHX |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | KRB |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-17 |
| Decision Date | 2018-09-04 |
| Summary: | summary |