Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K161465 |
Device Name |
CardioConfirm |
Applicant |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH STREET |
Milwaukee,
WI
53224
|
|
Applicant Contact |
Margaret Mucha |
Correspondent |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH STREET |
Milwaukee,
WI
53224
|
|
Correspondent Contact |
Margaret Mucha |
Regulation Number | 870.1425
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/27/2016 |
Decision Date | 09/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|