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 Interferential Current Therapy
510(k) Number K941461
Device Name DYNATRON 850
Applicant
Dynatronics Research Corp.
7030 Park Centre Dr.
Salt Lake City,  UT  84121
Applicant Contact JOHN S RAMEY
Correspondent
Dynatronics Research Corp.
7030 Park Centre Dr.
Salt Lake City,  UT  84121
Correspondent Contact JOHN S RAMEY
Regulation Number882.5890
Classification Product Code
LIH  
Subsequent Product Codes
GZJ   IMG   IMI   IPF  
Date Received03/24/1994
Decision Date 09/01/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-