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.01 And Intellivue Clinical Network On Vlan.
Device ID | K040955 |
510k Number | K040955 |
Device Name: | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN |
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 | 2004-04-13 |
Decision Date | 2004-05-12 |
Summary: | summary |