The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Patient Monitors Mp2, Mp5, Mp5t, Mp5sc, And Multi-measurement Module X2; Intellivue Patient Monitors Mp20, Mp30, Mp40, Mp50, Mp60; Intellivue Patient Monitors Mp70, Mp80, Mp90;intellivue Patient Monitors Mx400, Mx430, Mx450, Mx500, Mx550, .
| Device ID | K161531 |
| 510k Number | K161531 |
| Device Name: | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, And Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, |
| 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 | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2016-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838076532 | K161531 | 000 |