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, Dental Sonography, For Monitoring Jaw Sounds
510(k) Number K905449
Device Name ELECTROSONOGRAM ESG-1
Applicant
Myo-Tronics, Inc.
720 Olive Way Suite 800
Seattle,  WA  98101
Applicant Contact FRAY ADIB
Correspondent
Myo-Tronics, Inc.
720 Olive Way Suite 800
Seattle,  WA  98101
Correspondent Contact FRAY ADIB
Regulation Number872.2050
Classification Product Code
NFQ  
Subsequent Product Code
NFS  
Date Received12/05/1990
Decision Date 04/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-