The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Intellibridge System.
| Device ID | K093177 |
| 510k Number | K093177 |
| Device Name: | INTELLIBRIDGE SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Claire Arakaki |
| Correspondent | Claire Arakaki PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-08 |
| Decision Date | 2009-12-18 |
| Summary: | summary |