Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K943698 |
Device Name |
STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES |
Applicant |
ZOLL MEDICAL CORP. |
32 SECOND AVE. |
BURLINGTON,
MA
01803 -4420
|
|
Applicant Contact |
BLAKE A CERULLO |
Correspondent |
ZOLL MEDICAL CORP. |
32 SECOND AVE. |
BURLINGTON,
MA
01803 -4420
|
|
Correspondent Contact |
BLAKE A CERULLO |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 07/29/1994 |
Decision Date | 12/28/1994 |
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
|