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, muscle monitoring
510(k) Number K944134
Device Name K6-1 DIAGNOSTIC SYSTEM VERSION 3.1
Applicant
MYO-TRONICS, INC.
15425 - 33RD AVENUE SOUTH
TUKWILA,  WA  98188
Applicant Contact FRAY ADIB
Correspondent
MYO-TRONICS, INC.
15425 - 33RD AVENUE SOUTH
TUKWILA,  WA  98188
Correspondent Contact FRAY ADIB
Regulation Number890.1375
Classification Product Code
KZM  
Subsequent Product Code
NFS  
Date Received08/24/1994
Decision Date 12/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-