• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name stimulator, muscle, powered
510(k) Number K120922
Device Name GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
Original Applicant
SELECTIVEMED COMPONENTS INC.
8870 ravello ct
naples,  FL  34114
Original Contact daniel kamm
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/27/2012
Decision Date 02/07/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-