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 K973529
Device Name NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
Applicant
Medicotest A/S
1900 K St. NW
Washington,  DC  20006 -1108
Applicant Contact EMALEE G MURPHY
Correspondent
Medicotest A/S
1900 K St. NW
Washington,  DC  20006 -1108
Correspondent Contact EMALEE G MURPHY
Regulation Number890.1385
Classification Product Code
IKT  
Date Received09/18/1997
Decision Date 11/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-