ZOLL X SERIES


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K112432
Device Name ZOLL X SERIES
Applicant
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 mill road
chelmsford, 
MA 
01824 -4105

Applicant Contact charles w kolifrath
Correspondent
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 mill road
chelmsford, 
MA 
01824 -4105

Correspodent Contact charles w kolifrath
Regulation Number 870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   DRO   DRT   DSK  
DXN   LDD   LIX  
Date Received 08/23/2011
Decision Date 03/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls