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 Interventional Fluoroscopic X-Ray System
510(k) Number K142273
Device Name EmboGuide
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Applicant Contact Liselotte Kornmann
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Correspondent Contact Liselotte Kornmann
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAK   LLZ  
Date Received08/15/2014
Decision Date 01/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-