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 Device, Biofeedback
510(k) Number K915858
Device Name MYOTRAC2
Applicant
THOUGHT TECHNOLOGY LTD.
2180 BELGRAVE AVE.
MONTREAL, QUEBEC,  CA H4A 2L8
Applicant Contact HAL K MYERS
Correspondent
THOUGHT TECHNOLOGY LTD.
2180 BELGRAVE AVE.
MONTREAL, QUEBEC,  CA H4A 2L8
Correspondent Contact HAL K MYERS
Regulation Number882.5050
Classification Product Code
HCC  
Date Received12/27/1991
Decision Date 09/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-