• 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, cutaneous
510(k) Number K142159
Device Name DISPOSABLE PRE-GELLED SURFACE ELECTRODE
Applicant
ROCHESTER ELECTRO MEDICAL, INC.
19404 PINE VALLEY DRIVE
odessa,  FL  33556
Applicant Contact wayne glover
Correspondent
ROCHESTER ELECTRO MEDICAL, INC.
19404 PINE VALLEY DRIVE
odessa,  FL  33556
Correspondent Contact wayne glover
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/06/2014
Decision Date 06/03/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-