ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K081081
Device Name ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
Applicant
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 mill road
chelmsford, 
MA 
01824 -4105

Applicant Contact eileen m boyle
Correspondent
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 mill road
chelmsford, 
MA 
01824 -4105

Correspodent Contact eileen m boyle
Regulation Number 870.5310
Classification Product Code
MKJ  
Date Received 04/16/2008
Decision Date 03/09/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No