The following data is part of a premarket notification filed by Phillips Medical Systems with the FDA for Intellivue Mx40 Patient Monitor.
| Device ID | K103646 |
| 510k Number | K103646 |
| Device Name: | INTELLIVUE MX40 PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILLIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Claire Arakaki |
| Correspondent | Claire Arakaki PHILLIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-14 |
| Decision Date | 2011-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838082229 | K103646 | 000 |
| 00884838082212 | K103646 | 000 |
| 00884838082205 | K103646 | 000 |
| 00884838082199 | K103646 | 000 |