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 Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K872529
Device Name THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
Applicant
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711
Applicant Contact HAYIM ZADACA
Correspondent
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711
Correspondent Contact HAYIM ZADACA
Regulation Number870.1435
Classification Product Code
DXG  
Date Received06/26/1987
Decision Date 09/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-