510(k) Premarket Notification

• Device Classification Name: monitor,physiological,patient(without arrhythmia detection or alarms)
• 510(K) Number: K013470
• Device Name: MODIFICATION TO M2376A DEVICELINK SYSTEM
• Applicant: PHILIPS MEDICAL SYSTEMS, INC.; 3000 minuteman rd.; andover, MA 01810 1099
• Contact: mike hudon
• Regulation Number: 870.2300
• Classification Product Code: MWI
• Date Received: 10/18/2001
• Decision Date: 11/14/2001
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No