Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K042417 |
Device Name |
ZOLL M SERIES ETC02 LOFLO OPTION |
Applicant |
ZOLL MEDICAL CORP. |
269 MILL ROAD |
CHELMSFORD,
MA
01824 -4105
|
|
Applicant Contact |
SEAN REYNOLDS |
Correspondent |
ZOLL MEDICAL CORP. |
269 MILL ROAD |
CHELMSFORD,
MA
01824 -4105
|
|
Correspondent Contact |
SEAN REYNOLDS |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/07/2004 |
Decision Date | 10/05/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|