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 | K143057 |
510k Number | K143057 |
Device Name: | M3290B Philips IntelliVue Information Center IX |
Classification | System, Network And Communication, Physiological Monitors |
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 | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-24 |
Decision Date | 2014-12-03 |
Summary: | summary |