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 K850868
Device Name MFE CARDIAC STRESS SYSTEM
Applicant
Ketronic, Inc.
Duinkerkenlaan 31
5627 Ma Eindhoven
The Netherlands,  NL
Applicant Contact VAN DIL
Correspondent
Ketronic, Inc.
Duinkerkenlaan 31
5627 Ma Eindhoven
The Netherlands,  NL
Correspondent Contact VAN DIL
Date Received03/01/1985
Decision Date 06/12/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-