Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K110978 |
Device Name |
ONESTEP PEDIATRIC MFE'S |
Applicant |
ZOLL MEDICAL CORPORATION |
525 NARRAGANSETT PARK DRIVE |
PAWTUCKET,
RI
02861
|
|
Applicant Contact |
ROBERT MORSE |
Correspondent |
ZOLL MEDICAL CORPORATION |
525 NARRAGANSETT PARK DRIVE |
PAWTUCKET,
RI
02861
|
|
Correspondent Contact |
ROBERT MORSE |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 04/07/2011 |
Decision Date | 05/13/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|