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 Table, Radiographic, Stationary Top
510(k) Number K914351
Device Name CLINITRON C-10
Applicant
Ssi Medical Services, Inc.
Burditt Radzius Chartered
333 W.Wacker Dr.Suite 2600
Chicago,  IL  60606
Applicant Contact JOHN F.LEMKER
Correspondent
Ssi Medical Services, Inc.
Burditt Radzius Chartered
333 W.Wacker Dr.Suite 2600
Chicago,  IL  60606
Correspondent Contact JOHN F.LEMKER
Regulation Number892.1980
Classification Product Code
IXQ  
Date Received09/27/1991
Decision Date 02/14/1992
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
-
-