The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Patient Monitors Mx100, Mx400, Mx430, Mx450, Mx500, Mx550, Intellivue Patient Monitors Mx700, Mx800, Intellivue Patient Monitors Mp5, Mp5sc, Multi-measurement Module X3.
| Device ID | K182979 |
| 510k Number | K182979 |
| Device Name: | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen, DE 71034 |
| Contact | Markus Stacha |
| Correspondent | Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen, DE 71034 |
| Product Code | MHX |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | MLD |
| Subsequent Product Code | MSX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-26 |
| Decision Date | 2019-11-19 |
| Summary: | summary |