• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography
510(k) Number DEN120016
Device Name DEKA ARM SYSTEM
Original Applicant
DEKA INTEGRATED SOLUTIONS CORPORATION
340 commercial street
manchester,  NH  03101
Original Contact roger leroux
Regulation Number890.3450
Classification Product Code
PAE  
Date Received06/15/2012
Decision Date 05/09/2014
Decision an (AN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Post-NSE
Reviewed by Third Party No
Combination Product No
-
-