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 Stimulator, Nerve, Battery-Powered
510(k) Number K904025
Device Name MYOTRACK, MODEL HH 515
Applicant
Myotrack Co.
P.O. Box 56025
Van Nuys,  CA  91413
Applicant Contact FREDERIC P TORRES
Correspondent
Myotrack Co.
P.O. Box 56025
Van Nuys,  CA  91413
Correspondent Contact FREDERIC P TORRES
Regulation Number868.2775
Classification Product Code
BXN  
Date Received08/30/1990
Decision Date 03/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-