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 K910654
Device Name CINEMEASURE (TM)
Applicant
Syracuse Research Corp.
Merrill Ln.
Syracuse,  NY  13210
Applicant Contact STANLEY N HACK
Correspondent
Syracuse Research Corp.
Merrill Ln.
Syracuse,  NY  13210
Correspondent Contact STANLEY N HACK
Regulation Number892.1600
Classification Product Code
IZI  
Date Received02/14/1991
Decision Date 06/06/1991
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
-
-