The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for M3290b Philips Intellivue Information Center Ix.
| Device ID | K153702 |
| 510k Number | K153702 |
| Device Name: | M3290B Philips IntelliVue Information Center IX |
| 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 | DSH |
| Subsequent Product Code | DSI |
| Subsequent Product Code | MLD |
| Subsequent Product Code | MSX |
| Subsequent Product Code | OUG |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-06-13 |
| Summary: | summary |