The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Intellisphere Event Managment System Rel. 10.00.
| Device ID | K102974 |
| 510k Number | K102974 |
| Device Name: | INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | PHILIPS MEDICAL SYSTEMS 6400 N. CONGRESS AVE. SUITE 1050 Boca Raton, FL 33487 -2810 |
| Contact | Gary Becker |
| Correspondent | Gary Becker PHILIPS MEDICAL SYSTEMS 6400 N. CONGRESS AVE. SUITE 1050 Boca Raton, FL 33487 -2810 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-06 |
| Decision Date | 2011-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838031746 | K102974 | 000 |