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 Tube Mount, X-Ray, Diagnostic
510(k) Number K941017
Device Name F/C/W TUBESTAND
Applicant
Acoma Medical Imaging, Inc.
150 Chaddick Dr.
Wheeling,  IL  60090
Applicant Contact JAMES LAMBRECHT
Correspondent
Acoma Medical Imaging, Inc.
150 Chaddick Dr.
Wheeling,  IL  60090
Correspondent Contact JAMES LAMBRECHT
Regulation Number892.1770
Classification Product Code
IYB  
Date Received03/03/1994
Decision Date 07/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-