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 Ultrasound, Infusion, System
510(k) Number K053437
Device Name EKOS MICRO-INFUSION SYSTEM
Applicant
Ekos Corp.
22030 20th Ave. SE
Suite 101
Bothell,  WA  98021
Applicant Contact JOCELYN KERSTEN
Correspondent
Ekos Corp.
22030 20th Ave. SE
Suite 101
Bothell,  WA  98021
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.1200
Classification Product Code
NUI  
Date Received12/09/2005
Decision Date 01/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-