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 Electrocardiograph
510(k) Number K121825
Device Name CS-MAG II
Applicant
Biomagnetik-Park GmbH
Beim Strohhause 27
Hamburg,  DE 20097
Applicant Contact THOMAS WEBER
Correspondent
Biomagnetik-Park GmbH
Beim Strohhause 27
Hamburg,  DE 20097
Correspondent Contact THOMAS WEBER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/21/2012
Decision Date 03/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-