Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Blood Pressure Cuff
510(k) Number K152006
Device Name Cogent Hemodynamic Monitoring System
Applicant
ICU MEDICAL INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Applicant Contact Natalie Hepworth
Correspondent
ICU MEDICAL INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Correspondent Contact Natalie Hepworth
Regulation Number870.1120
Classification Product Code
DXQ  
Subsequent Product Code
DQA  
Date Received07/21/2015
Decision Date 05/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-