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 electromyograph, diagnostic
510(k) Number K974385
Device Name MLS ELECTROMYOGRAPHIC PREAMPLIFIER
Applicant
MOTION LAB SYSTEMS, INC.
4326 PINE PARK DR.
BATON ROUGE,  LA  70809 -2397
Applicant Contact EDMUND CRAMP
Correspondent
MOTION LAB SYSTEMS, INC.
4326 PINE PARK DR.
BATON ROUGE,  LA  70809 -2397
Correspondent Contact EDMUND CRAMP
Regulation Number890.1375
Classification Product Code
IKN  
Date Received11/21/1997
Decision Date 02/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-