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 System, Nuclear Magnetic Resonance Imaging
510(k) Number K992120
Device Name DYNAWELL OR DYNAWELL
Applicant
Ekeroth Quality AB
Nybrokajen 7
Stockholm,  SE 102 41
Applicant Contact NILS EKEROTH
Correspondent
Ekeroth Quality AB
Nybrokajen 7
Stockholm,  SE 102 41
Correspondent Contact NILS EKEROTH
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
JAK  
Date Received06/23/1999
Decision Date 08/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-