• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K122095
Device Name ICP TRIAGEMANAGER
Original Applicant
EMERGO EUROPE CONSULTING BV
prinsessegracht 20
den haag,  NL 2514
Original Contact rachida ziani
Regulation Number870.2910
Classification Product Code
DRG  
Date Received07/12/2012
Decision Date 07/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
-
-