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 camera, multi format, radiological
510(k) Number K964414
Device Name LR 5200 LASER FILM RECORDER
Applicant
BAYER CORP., AGFA DIV.
100 CHALLENGER RD.
RIDGEFIELD PARK,  NJ  07660
Applicant Contact MICHAEL SULLIVAN
Correspondent
BAYER CORP., AGFA DIV.
100 CHALLENGER RD.
RIDGEFIELD PARK,  NJ  07660
Correspondent Contact MICHAEL SULLIVAN
Regulation Number892.2040
Classification Product Code
LMC  
Date Received11/05/1996
Decision Date 01/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-