CareEvent

System, Network And Communication, Physiological Monitors

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Careevent.

Pre-market Notification Details

• Device ID: K142935
• 510k Number: K142935
• Device Name: CareEvent
• 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: 2014-10-09
• Decision Date: 2015-01-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838053441	K142935	000