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, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K990055
Device Name B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
Applicant
Omega Medical Imaging, Inc.
675 Hickman Cir.
Sanford,  FL  32771
Applicant Contact DOUGLAS M COON
Correspondent
Omega Medical Imaging, Inc.
675 Hickman Cir.
Sanford,  FL  32771
Correspondent Contact DOUGLAS M COON
Regulation Number892.1650
Classification Product Code
JAA  
Date Received01/07/1999
Decision Date 02/02/1999
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
-
-