Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K092598 |
Device Name |
ZOLL E SERIES WITH SPCO/SPMET OPTION |
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
|
|
Correspondent Contact |
EILEEN M BOYLE |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/24/2009 |
Decision Date | 12/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|