Device Classification Name |
cable, transducer and electrode, patient, (including connector)
|
510(k) Number |
K102430 |
Device Name |
TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET |
Applicant |
TYCO ELECTRONICS CORPORATION |
10025 SW FREEMAN CT. |
WILSONVILLE,
OR
97070
|
|
Applicant Contact |
DENNIS M GILKEY |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
DAWN TIBODEAU |
Regulation Number | 870.2900
|
Classification Product Code |
|
Date Received | 08/26/2010 |
Decision Date | 09/10/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|