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
510(k) Number K935589
Device Name CENTRA HEART STATION
Applicant
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact KRISTIN PABST
Correspondent
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact KRISTIN PABST
Classification Product Code
LOS
Date Received11/18/1993
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-