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
510(k) Number K121347
Device Name PRESSON ELECTRODE
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 Number882.1350
Classification Product Code
GXZ  
Date Received05/01/2012
Decision Date 07/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-