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 electrode, electrocardiograph
510(k) Number K921164
Device Name MODEL 1300 SOFTRACE II ELECTRODE
Applicant
MEDTRONIC VASCULAR
60 NEWARK ST.
HAVERHILL,  MA  01830
Applicant Contact JANICE M PEVIDE
Correspondent
MEDTRONIC VASCULAR
60 NEWARK ST.
HAVERHILL,  MA  01830
Correspondent Contact JANICE M PEVIDE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received03/11/1992
Decision Date 03/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-