Device Classification Name |
electrode, electrocardiograph |
|||
---|---|---|---|---|
510(k) Number | K023503 | |||
Device Name | SKINTACT ECG ELECTRODE | |||
Original Applicant |
|
|||
Original Contact | elaine duncan | |||
Regulation Number | 870.2360 | |||
Classification Product Code |
|
|||
Date Received | 10/18/2002 | |||
Decision Date | 11/14/2002 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
Cardiovascular |
|||
summary |
summary |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |