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 Electrode, Needle, Diagnostic Electromyograph
510(k) Number K120342
Device Name EMG RECORDING ELECTRODE ASSEMBLY
Applicant
RHYTHMLINK INTERNATIONAL, LLC
1140 FIRST ST. SOUTH
COLUMBIA,  SC  29209
Applicant Contact JAMES MEWBORNE
Correspondent
RHYTHMLINK INTERNATIONAL, LLC
1140 FIRST ST. SOUTH
COLUMBIA,  SC  29209
Correspondent Contact JAMES MEWBORNE
Regulation Number890.1385
Classification Product Code
IKT  
Subsequent Product Code
GXZ  
Date Received02/03/2012
Decision Date 06/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-