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 cable, transducer and electrode, patient, (including connector)
510(k) Number K110287
Device Name PHILIPS ECG LEADWIRE SET
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Applicant Contact PETER SCHIPELLITI
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact DAWN TIBODEAU
Regulation Number870.2900
Classification Product Code
DSA  
Date Received01/31/2011
Decision Date 02/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
-
-