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 K103477
FOIA Releasable 510(k) K103477
Device Name PERMOBIL M300 / M400
Applicant
Permobil AB
Box 120 S-861 23
Timra,  SE
Applicant Contact JAN ASTROM
Correspondent
Permobil AB
Box 120 S-861 23
Timra,  SE
Correspondent Contact JAN ASTROM
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/26/2010
Decision Date 03/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-