The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for M3290a Intellivue Information Center Software Release E.1.
| Device ID | K031403 |
| 510k Number | K031403 |
| Device Name: | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | David Osborn |
| Correspondent | David Osborn PHILIPS MEDICAL SYSTEMS, INC. 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 | 2003-05-05 |
| Decision Date | 2003-05-30 |
| Summary: | summary |