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, Scintillation (Gamma)
510(k) Number K853482
Device Name ACE COMPUTER SYSTEM
Applicant
Cardiac Medical Systems Corp.
P.O. Box 45
Springfield,  WI  53176
Applicant Contact JOHN HATTON
Correspondent
Cardiac Medical Systems Corp.
P.O. Box 45
Springfield,  WI  53176
Correspondent Contact JOHN HATTON
Regulation Number892.1100
Classification Product Code
IYX  
Date Received08/20/1985
Decision Date 01/01/1986
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
-
-