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 K990375
Device Name DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
Applicant
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18
Skovlunde
Copenhagen,  DK DK-2740
Applicant Contact ANN-CHRISTINE JONSSON
Correspondent
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18
Skovlunde
Copenhagen,  DK DK-2740
Correspondent Contact ANN-CHRISTINE JONSSON
Regulation Number890.1385
Classification Product Code
IKT  
Date Received02/08/1999
Decision Date 03/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-