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, Simulation, Radiation Therapy
510(k) Number K921876
Device Name MKS BEAM OUTLINE PROJECTOR
Applicant
Medical Knowledge Systems, Inc.
3800 Woodward Ave.
Suite 900
Detroit,  MI  48201
Applicant Contact DON P RAGAN
Correspondent
Medical Knowledge Systems, Inc.
3800 Woodward Ave.
Suite 900
Detroit,  MI  48201
Correspondent Contact DON P RAGAN
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received04/20/1992
Decision Date 06/25/1992
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
-
-