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 K843920
Device Name FLUOROSCAN/TM BY HEALTHMATE
Applicant
HEALTHMATE, INC.
3000 DUNDEE ROAD
NORTHBROOK,  IL  60062 -
Applicant Contact KEN WIESELMAN
Correspondent
HEALTHMATE, INC.
3000 DUNDEE ROAD
NORTHBROOK,  IL  60062 -
Correspondent Contact KEN WIESELMAN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/05/1984
Decision Date 02/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-