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 K091513
Device Name SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
Applicant
EDAN INSTRUMENTS, INC.
1 ODELL PLAZA
YONKERS,  NY  10701
Applicant Contact WILLIAM STERN
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/22/2009
Decision Date 07/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
-
-