Device Classification Name |
pacemaker, cardiac, external transcutaneous (non-invasive)
|
510(k) Number |
K012218 |
Device Name |
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES |
Applicant |
THE LUDLOW COMPANY LP |
TWO LUDLOW PARK DR. |
CHICOPEE,
MA
01022
|
|
Applicant Contact |
KATHLEEN M TREMBLAY |
Correspondent |
THE LUDLOW COMPANY LP |
TWO LUDLOW PARK DR. |
CHICOPEE,
MA
01022
|
|
Correspondent Contact |
KATHLEEN M TREMBLAY |
Regulation Number | 870.5550
|
Classification Product Code |
|
Date Received | 07/16/2001 |
Decision Date | 10/12/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|