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 Programmer, Changer, Film/Cassette, Radiographic
510(k) Number K904103
Device Name SEP 90
Applicant
Elema-Schonander, Inc.
2360 N. Palmer Dr.
Schaumburg,  IL  60173
Applicant Contact ELLEN FARNEY
Correspondent
Elema-Schonander, Inc.
2360 N. Palmer Dr.
Schaumburg,  IL  60173
Correspondent Contact ELLEN FARNEY
Regulation Number892.1870
Classification Product Code
IZP  
Date Received09/06/1990
Decision Date 11/20/1990
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
-
-