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 Automated External Defibrillators (Non-Wearable)
510(k) Number K033474
Device Name ZOLL AED PLUS
Applicant
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact PAUL DIAS
Correspondent
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact PAUL DIAS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received11/03/2003
Decision Date 05/21/2004
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
Recalls CDRH Recalls
-
-