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 Computer, Diagnostic, Programmable
510(k) Number K180940
Device Name KODEX EPD System
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Pc Best,  NL 5684
Applicant Contact Gina Crossetta
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Pc Best,  NL 5684
Correspondent Contact Gina Crossetta
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/10/2018
Decision Date 10/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-