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 Device, Beam Limiting, X-Ray, Diagnostic
510(k) Number K904489
Device Name EUREKA EXTENSION CYLINDERS
Applicant
Eureka X-Ray Tube Corp.
600 W. University Dr.
Arlington Heights,  IL  60004
Applicant Contact RAYMOND OLSON
Correspondent
Eureka X-Ray Tube Corp.
600 W. University Dr.
Arlington Heights,  IL  60004
Correspondent Contact RAYMOND OLSON
Regulation Number892.1610
Classification Product Code
KPW  
Date Received10/02/1990
Decision Date 10/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-