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, Powered
510(k) Number K960951
Device Name PERMOBIL CHAIRMAN L/CS 8
Applicant
Permobil AB
Box 120 S-861 23
Timra,  SE
Applicant Contact BENGT PERSSON
Correspondent
Permobil AB
Box 120 S-861 23
Timra,  SE
Correspondent Contact BENGT PERSSON
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/11/1996
Decision Date 04/30/1997
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
-
-