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
|
|
Correspondent Contact |
CHARLES W KOLIFRATH |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Codes |
|
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
|
|
|