Device Classification Name |
electrocardiograph,ambulatory(without analysis) |
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---|---|---|---|---|---|
510(k) Number | K122272 | ||||
Device Name | CARDIOMEM | ||||
Applicant |
|
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Applicant Contact | susan d goldstein-falk | ||||
Correspondent |
|
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Correspodent Contact | susan d goldstein-falk | ||||
Regulation Number | 870.2800 | ||||
Classification Product Code |
|
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Date Received | 07/30/2012 | ||||
Decision Date | 03/28/2013 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
Cardiovascular |
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summary |
summary |
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Type | Special | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |