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 K854433
Device Name ECG MONITORING/DEFIBRILLATION ELECTRODE
Applicant
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact EDWARD SHAUGHNESSY
Correspondent
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact EDWARD SHAUGHNESSY
Regulation Number870.2360
Classification Product Code
DRX  
Date Received11/05/1985
Decision Date 05/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-