Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K120406 |
FOIA Releasable 510(k) |
K120406
|
Device Name |
ZOLL FULLY AUTOMATIC AED PLUS |
Applicant |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
269 MILL ROAD |
CHELMSFORD,
MA
01824 -4105
|
|
Applicant Contact |
TANMAY B SHUKLA |
Correspondent |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
269 MILL ROAD |
CHELMSFORD,
MA
01824 -4105
|
|
Correspondent Contact |
TANMAY B SHUKLA |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 02/09/2012 |
Decision Date | 10/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|