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 Injector, Fluid, Non-Electrically Powered
510(k) Number K003864
Device Name INJEX 50 SYSTEM
Applicant
EQUIDYNE SYSTEMS, INC.
11770 BERNARDO PLAZA CT.
SUITE 351
SAN DIEGO,  CA  92128
Applicant Contact JIM BARLEY
Correspondent
EQUIDYNE SYSTEMS, INC.
11770 BERNARDO PLAZA CT.
SUITE 351
SAN DIEGO,  CA  92128
Correspondent Contact JIM BARLEY
Regulation Number880.5430
Classification Product Code
KZE  
Date Received12/13/2000
Decision Date 03/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-