The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Careevent Inclusive Of The Careevent Mobile Application Accessory.
| Device ID | K161164 |
| 510k Number | K161164 |
| Device Name: | CareEvent Inclusive Of The CareEvent Mobile Application Accessory |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-25 |
| Decision Date | 2016-06-24 |
| Summary: | summary |