The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Patient Monitor Mx750, Intellivue Patient Monitor Mx850, Intellivue 4-slot Module Rack Fmx-4.
| Device ID | K210906 |
| 510k Number | K210906 |
| Device Name: | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot Module Rack FMX-4 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Strasse 2 Boeblingen, DE 71034 |
| Contact | Monica Da Silva |
| Correspondent | Monica Da Silva Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Strasse 2 Boeblingen, DE 71034 |
| Product Code | MHX |
| Subsequent Product Code | BZC |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSF |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | GWS |
| Subsequent Product Code | KLK |
| Subsequent Product Code | KOI |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-26 |
| Decision Date | 2021-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086982 | K210906 | 000 |
| 00884838083332 | K210906 | 000 |
| 00884838070790 | K210906 | 000 |