Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K011388 |
Device Name |
ZOLL PAD |
Applicant |
ZOLL MEDICAL CORP. |
32 SECOND AVE. |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
PAUL DIAS |
Correspondent |
ZOLL MEDICAL CORP. |
32 SECOND AVE. |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
PAUL DIAS |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 05/07/2001 |
Decision Date | 03/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|