The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Mx40 Release C.01.
| Device ID | K180017 |
| 510k Number | K180017 |
| Device Name: | MX40 Release C.01 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 |
| Contact | Theresa Poole |
| Correspondent | Theresa Poole Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 |
| Product Code | MHX |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DRW |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSI |
| 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 | 2018-01-02 |
| Decision Date | 2018-07-24 |
| Summary: | summary |