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 K133484
Device Name ZOLL X SERIES
Applicant
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact TANMAY SHUKLA
Correspondent
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact TANMAY SHUKLA
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   DRO   DRT   DSK  
DXN   LDD   LIX  
Date Received11/13/2013
Decision Date 08/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-