Device Classification Name |
electrocardiograph
|
510(k) Number |
K082946 |
Device Name |
MORTARA ELI 350 ELECTROCARDIOGRAPH |
Applicant |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Applicant Contact |
CHARLES MORREALE |
Correspondent |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Correspondent Contact |
CHARLES MORREALE |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 10/02/2008 |
Decision Date | 12/29/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|