• 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 K042007
Device Name ZOLL E SERIES DEFIBRILLATOR
Applicant
Zoll Medical Corp
269 Mill Rd.
Chelmsford,  MA  01824 -4105
Applicant Contact SEAN REYNOLDS
Correspondent
Zoll Medical Corp
269 Mill Rd.
Chelmsford,  MA  01824 -4105
Correspondent Contact SEAN REYNOLDS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/26/2004
Decision Date 04/07/2005
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
-
-