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, Angiographic
510(k) Number K970738
Device Name KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT
Applicant
Jamieson Film Co.
Health Sciences Division
901 Elmgrove Rd.
Rochester,  NY  14653
Applicant Contact DAN NEWMAN
Correspondent
Jamieson Film Co.
Health Sciences Division
901 Elmgrove Rd.
Rochester,  NY  14653
Correspondent Contact DAN NEWMAN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received02/28/1997
Decision Date 05/07/1997
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
-
-