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, Film Marking, Radiographic
510(k) Number K911873
Device Name X-MARX
Applicant
Macbrud Corp. Medical Div.
6280 Sunset Dr. #411
Miami,  FL  33143
Applicant Contact BANNING G LARY
Correspondent
Macbrud Corp. Medical Div.
6280 Sunset Dr. #411
Miami,  FL  33143
Correspondent Contact BANNING G LARY
Regulation Number892.1640
Classification Product Code
JAC  
Date Received04/29/1991
Decision Date 07/19/1991
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
-
-