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 Wheelchair, Mechanical
510(k) Number K911119
Device Name SOPUR GMBH WHEELCHAIRS
Applicant
Sopur GmbH
Postfach 4080, Industriegebiet
D-6911 Malsch
Heidelberg, Germany,  GR
Applicant Contact ERROL MARKLEIN
Correspondent
Sopur GmbH
Postfach 4080, Industriegebiet
D-6911 Malsch
Heidelberg, Germany,  GR
Correspondent Contact ERROL MARKLEIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/11/1991
Decision Date 07/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-