• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, network and communication, physiological monitors
510(k) Number K161164
Device Name CareEvent inclusive of the CareEvent Mobile Application accessory
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN ROAD
andover,  MA  01810
Applicant Contact theresa poole
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN ROAD
andover,  MA  01810
Correspondent Contact theresa poole
Regulation Number870.2300
Classification Product Code
MSX  
Date Received04/25/2016
Decision Date 06/24/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-