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 Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K926056
Device Name 9600 FLUOROSCOPIC IMAGING SYSTEM
Applicant
OEC-DIASONICS, INC.
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Applicant Contact THOMAS R MEYERS
Correspondent
OEC-DIASONICS, INC.
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact THOMAS R MEYERS
Regulation Number892.1650
Classification Product Code
OXO  
Date Received12/01/1992
Decision Date 01/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-