Device Classification Name |
Electrode, Electrocardiograph
|
510(k) Number |
K090180 |
Device Name |
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE |
Applicant |
VERMED, INC. |
9 LOVELL DR. |
BELLOWS FALLS,
VT
05101
|
|
Applicant Contact |
MARC FILLION |
Correspondent |
VERMED, INC. |
9 LOVELL DR. |
BELLOWS FALLS,
VT
05101
|
|
Correspondent Contact |
MARC FILLION |
Regulation Number | 870.2360 |
Classification Product Code |
|
Date Received | 01/23/2009 |
Decision Date | 06/17/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|