The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Intellivue Mx40 Patient Monitor.
| Device ID | K113125 |
| 510k Number | K113125 |
| Device Name: | INTELLIVUE MX40 PATIENT MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Theresa Poole |
| Correspondent | Theresa Poole PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | DSI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DRW |
| Subsequent Product Code | DSA |
| Subsequent Product Code | MHX |
| 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 | 2011-10-24 |
| Decision Date | 2011-11-17 |
| Summary: | summary |